publications

President Trump signed a new Executive Order (EO) on Gold Standard Childhood Vaccine Recommendations. The EO is intended to reaffirm that the United States (U.S.) vaccine policy reflects the best available scientific evidence and established practices from peer developed countries while maintaining access to currently approved vaccines. The Gold Standard Childhood Vaccine Recommendations are based on three distinct categories of childhood immunization recommendations:

Vaccines recommended for all children: measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type B, pneumococcal disease, human papillomavirus and varicella
Vaccines recommended for certain high-risk groups or populations: respiratory syncytial virus monoclonal antibodies, hepatitis A, hepatitis B, meningococcal B, meningococcal ACWY and dengue
Vaccines based on shared clinical decision-making: hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza and coronavirus disease 2019 (COVID-19)

Furthermore, the EO recommends that the combined measles, mumps and rubella (MMR) vaccine be administered in three separate, single-disease shots upon commercial availability in the United States. In addition, it is recommended that all childhood vaccines be administered at separate medical visits as much as possible. The Secretary of the Department of Health and Human Services (HHS), through the HHS Task Force on Safer Childhood Vaccines, is ordered to present plans within 90 days on options for administration of core childhood vaccines as single vaccines; evaluate the best timing and sequence of all core childhood vaccines, with childhood and adolescent vaccine schedules adjusted accordingly; develop alternative adjuvants to aluminum, as well as comparative safety/efficacy studies; continuously weigh the risks versus the benefits of all childhood vaccines; and improve vaccine safety monitoring, transparency and research. The Trump Administration states that federal programs and funding should promote parental choice regarding childhood vaccine decisions. HHS issued a Request for Information to gather public feedback on the categories in the federal vaccine recommendations and the incorporation of shared clinical decision-making.

The American Academy of Pediatrics (AAP) issued a statement in response to the EO. AAP vaccine recommendations are designed for children in the United States and are informed by decades of scientific research and real-world evidence. Vaccine recommendations are timed to maximize immune response and protect children during periods of highest disease vulnerability. The AAP states that the EO is not based on gold-standard science and that there is no new data to warrant these substantial revisions to childhood vaccine recommendations. The American College of Physicians (ACP) also issued a rebuttal in response to the EO.

A target trial emulation study published in The BMJ assessed the risk of alopecia among adults with type 2 diabetes mellitus (T2DM) initiating glucagon-like peptide-1 receptor agonists (GLP-1s) compared with sodium-glucose cotransporter-2 (SGLT-2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors using Penn Medicine electronic health record data from January 2019 to September 2024. After adjustment for baseline covariates between treatment groups using stabilized inverse probability of treatment weighting, GLP-1 use was associated with a higher risk of alopecia compared with SGLT-2 inhibitors (hazard ratio, 1.37; 95% confidence interval [CI], 1.08–1.73) and DPP-4 inhibitors (hazard ratio, 1.68; 95% CI, 1.28–2.2). This association was primarily driven by nonscarring alopecia, with hazard ratios of 1.53 (95% CI, 1.18–1.97) and 1.72 (95% CI, 1.28–2.31), respectively. Authors concluded an increased risk, although low, of nonscarring alopecia was observed in association with GLP-1 use in adults with T2DM.
Effective July 1, 2026, the new Medicare GLP-1 Bridge program began providing coverage for select GLP-1s for weight management, including orforglipron (Foundayo) tablets, semaglutide (Wegovy) injection or tablet formulations, and tirzepatide (Zepbound) KwikPen. Under the program, eligible participants have access to these therapies for $50 per month. To qualify for the program, adults must be enrolled in Medicare Part D drug coverage — through a standalone prescription drug plan or a Medicare health plan that includes drug coverage — and be ineligible to receive a GLP-1 through their existing Medicare drug benefit. To be eligible, individuals must not have T2DM, moderate-to-severe obstructive sleep apnea or fatty liver disease and must meet one of the following criteria: (1) body mass index (BMI) of ≥35 kg/m²; (2) BMI of ≥30 kg/m² with certain types of heart failure, difficult-to-control hypertension or stage 3a or higher chronic kidney disease; or (3) BMI ≥27 kg/m² with prediabetes, cardiovascular disease or cerebrovascular disease.

The Centers for Disease Control and Prevention (CDC) issued a Health Advisory about the risk for severe arboviral neuroinvasive disease in patients receiving B cell-depleting or B cell-modulating therapies, particularly anti-cluster of differentiation (CD)-20 monoclonal antibodies (mAbs). Arboviruses are ribonucleic acid (RNA) viruses transmitted by the bites of infected arthropods, primarily mosquitoes and ticks. Clinical manifestations range from asymptomatic infection to febrile illness and severe neurologic disease, such as aseptic meningitis, encephalitis or acute flaccid myelitis. Arthropods are most active during warmer months, and arboviral symptoms generally appear within days to weeks of a bite, though onset may be delayed in immunocompromised individuals. Food and Drug Administration (FDA)-approved, anti-CD20 mAbs include rituximab (Rituxan) and biosimilars, ocrelizumab (Ocrevus), ofatumumab (Arzerra, Kesimpta), ublituximab-xiiy (Briumvi), obinutuzumab (Gazyva) and ibritumomab tiuxetan (Zevalin). Published case reports of arboviral neuroinvasive disease in patients receiving anti-CD20 mAbs have indicated an overall mortality rate of approximately 40%, with many survivors experiencing persistent neurological complications. Because there are currently no approved treatments, preventive therapies or vaccines for endemic arboviral diseases in the United States, patients receiving therapies affecting B-cell function should take appropriate measures to avoid mosquito and tick bites.
The CDC, FDA, and public health officials at state and local levels are investigating a multistate outbreak of Cyclospora infections related to iceberg lettuce. Taylor Farms recalled all iceberg lettuce originating from central Mexico on July 17, 2026. Because the recalled products have passed their best-by dates, they should no longer be available for purchase or be present within restaurant and food service supply chains. Investigations into additional outbreaks and related illnesses across the country remain ongoing. Although most immunocompetent individuals ultimately recover from cyclosporiasis without treatment, symptoms (diarrhea, loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, fatigue, etc.) can be prolonged. Trimethoprim-sulfamethoxazole (TMP-SMX) remains the preferred treatment for cyclosporiasis.
As of Aug. 20, 2026, the CDC had reported 2,777 measles cases in the United States. According to the AAP, the number of cases in 2026 surpassed the total reported in 2025 by late July, making 2026 the most severe year for measles since 1991. Nearly 20% of measles cases reported to date in 2026 have occurred in children under 5 years of age, while 47% were reported among individuals 5–19 years of age. Most cases (94%) occurred in persons who were unvaccinated or had an unknown vaccination status, and 7% of cases resulted in hospitalization. The International Vaccine Access Center (IVAC) through Johns Hopkins also continues to monitor measles activity and reported 2,813 cases in the United States as of Aug. 21, 2026. The AAP continues to recommend routine MMR vaccination for all children, noting that the two-dose series is approximately 97% effective in preventing measles.

The FDA approved a new starting-dose regimen for the Alzheimer’s disease drug lecanemab-irmb (Leqembi Iqlik), enabling patients or caregivers to initiate the treatment at home via subcutaneous (SC) injection. Previously, treatment initiation required intravenous (IV) administration, with the option to transition to either IV or SC maintenance dosing after 18 months. The newly approved SC starting regimen consists of 500 mg administered once weekly using an autoinjector. The new initiation-dose launch is planned for late August 2026.
The FDA approved a new autoinjector for home administration of MannKind’s furosemide injection (Furoscix ReadyFlow) for the treatment of edema in adults with chronic heart failure or chronic kidney disease, including nephrotic syndrome. Previously, Furoscix was only available as the On-body Infusor, which delivered an initial 30 mg bolus dose SC over the first hour, followed by 12.5 mg per hour for the subsequent four hours. The autoinjector, Furoscix ReadyFlow, is prefilled to deliver 80 mg SC in approximately 10 seconds.
Unique Pharmaceutical Laboratories announced a voluntary, consumer-level recall of four lots of cetirizine hydrochloride (HCl) 5 mg tablets due to ranitidine cross-contamination. Patients with ranitidine hypersensitivity may be at risk for serious allergic reactions. The issue was identified after red-colored spots and discoloration were detected on affected tablets.
Fresenius Kabi recalled one lot of tocilizumab-aazg (Tyenne) injection 400 mg/20 mL vials to the user level due to the presence of glass particles. Administration of injectable products containing glass particles may cause injection site pain and irritation or severe complications, such as pulmonary embolism, organ obstruction or death.
The FDA released its 2025 drug shortages report. The report is submitted annually to Congress and outlines actions taken by the FDA during the previous calendar year to address drug shortages across the United States. The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) prevented 330 potential drug shortages through a range of mitigation strategies, including increased regulatory flexibility. While only four new drug shortages emerged — the lowest number of new shortages in a decade — a total of 93 ongoing shortages were reported at the close of the year.
The HHS and U.S. Department of Veterans Affairs announced a Memorandum of Understanding (MOU) that establishes a framework for preparing for future FDA-approved psychedelic drugs intended to treat serious behavioral health disorders.

The AAP released its recommendations for the prevention and management of influenza during the 2026–2027 season. Annual influenza vaccination remains recommended for all children 6 months of age and older who do not have contraindications, with no preference expressed for any specific vaccine product or formulation. The policy statement also includes recommendations on the use of antiviral treatment.
The American College of Chest Physicians (CHEST) published evidence-based recommendations on obstructive sleep apnea (OSA) in pregnancy. Given the limited certainty of evidence, nine conditional recommendations were developed addressing screening, evaluation and treatment strategies.
CHEST also released clinical practice guidelines for adult bronchiectasis, which is a chronic respiratory condition associated with recurrent infections, impaired mucus clearance, inflammation and progressive airway destruction. The guidelines provide 13 evidence-based recommendations covering acute exacerbation treatment, antibiotic therapy, airway clearance, long-term management strategies, hemoptysis management and the role of surgery in select patients.
An expert group consensus statement on rheumatoid arthritis (RA)-associated interstitial lung disease (ILD) was published in The Lancet Respiratory Medicine. Controlling RA disease activity is fundamental to the management of RA-associated ILD.
The Institute for Clinical and Economic Review (ICER) published its Final Evidence Report evaluating the clinical effectiveness and value of vaccines used to prevent COVID-19. The assessment includes Pfizer-BioNTech’s Comirnaty, Moderna’s Spikevax and mNexspike, and Sanofi’s Nuvaxovid.

Drug Approvals

Specialty

July 14, 2026 — gedatolisib (Revtorpyk)

New Drug Application (NDA) approval; Assessment Aid and Priority Review designations; Real-Time Oncology Review (RTOR) pilot program
Kinase inhibitor
Indicated in combination with fulvestrant (Faslodex), with or without palbociclib (Ibrance), for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting
Lyophilized powder: 180 mg in a single-dose vial for reconstitution and further dilution
Recommended dosage is administered as an IV infusion once weekly by a healthcare professional (HCP) on Days 1, 8 and 15 of a 28-day cycle; steroid-containing, alcohol-free mouthwash should be initiated prophylactically to decrease the incidence and severity of stomatitis
Approval was based on data from the open-label, randomized, multicenter VIKTORIA-1 trial (n=392) that enrolled adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer without a detectable PIK3CA mutation and with progression on or after treatment with a cyclin-dependent kinase (CDK4/6) inhibitor and a nonsteroidal aromatase inhibitor therapy; the primary endpoint was progression-free survival (PFS) for triplet therapy of gedatolisib in combination with fulvestrant and palbociclib, doublet therapy of gedatolisib in combination with fulvestrant, or fulvestrant monotherapy; the median PFS was 9.3 months in the gedatolisib-triplet group compared with 2 months in the fulvestrant alone group (hazard ratio for progression or death, 0.24; 95% CI, 0.17–0.35; P<0.001); the median PFS was 7.4 months in the gedatolisib-doublet arm (hazard ratio, 0.33; 95% CI, 0.24–0.48; P<0.001) compared with fulvestrant
The National Comprehensive Cancer Network (NCCN) invasive breast cancer guidelines include Faslodex/Revtorpyk, with or without Ibrance, as a Category 1 recommendation in the preferred second-line and/or subsequent-line therapy setting for HER-2 negative, ER- and/or progesterone receptor (PR)-positive postmenopausal or premenopausal patients receiving ovarian ablation or suppression for tumors without a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy; fulvestrant, in combination with a CDK4/6 inhibitor (e.g., abemaciclib [Verzenio], Ibrance, ribociclib [Kisqali]), is also included as a Category 1 recommendation for these patients if a CDK4/6 inhibitor was not previously used
Revtorpyk is available from Celcuity

July 22, 2026 — zidesamtinib (Jideytro)

NDA approval; Assessment Aid, Breakthrough Therapy and Orphan Drug designations; RTOR pilot program
Kinase inhibitor
Indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor
Oral tablets: 25 mg and 100 mg
Recommended dosage is taken orally once daily, with or without food, until disease progression or unacceptable toxicity
Approval was based on data from a multicenter, single-arm, open-label, multicohort trial (ARROS-1; n=117); patients enrolled had previously treated, locally advanced or metastatic, ROS1-positive NSCLC; the primary endpoints were overall response rate and duration of response; the overall response rate was 44% (95% CI, 34–53); a complete response occurred in 0.9% of patients; 82% of patients had a response duration of ≥6 months and 69% had a response duration of ≥12 months
The NCCN NSCLC guidelines include Jideytro as a subsequent therapy option for patients with ROS1 gene fusions, including resistant mutations such as ROS1 G2032R, for those who are asymptomatic or have symptomatic brain disease or symptomatic systemic disease with multiple lesions; other similarly recommended agents include repotrectinib (Augtyro), taletrectinib (Ibtrozi) and lorlatinib (Lorbrena)
Jideytro is available from GSK

Aug. 6, 2026 — vusolimogene oderparepvec-wtpg (Tudriqev)

Biologics License Application (BLA) approval; Accelerated Approval, Breakthrough Therapy and Priority Review designations
Genetically modified oncolytic viral therapy
Indicated in combination with nivolumab (Opdivo) for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed cell death protein 1 (PD-1)-blocking, antibody-based regimen; Accelerated Approval was based on objective response rate and duration of response; therefore, continued approval for this use may require demonstration of benefit in confirmatory trials
Suspension for injection: 10⁶ plaque-forming units (PFU) per mL and 10⁷ PFU per mL in single-dose vials
Recommended dosage is administered into the tumors via injection for superficial and deep/visceral lesions; deep/visceral lesion administration requires imaging technology; dosage is in mL/cm of the largest dimension of the tumor, for a maximum of 10 mL across all lesions treated per dose; the size of each lesion should be evaluated on the treatment day for determination of the injected volume; if multiple tumors are present, prioritization should be given to the most rapidly growing and largest new/existing lesions that are candidates for injection; administer every two weeks for eight consecutive doses; initiate at a concentration of 10⁶ PFU/mL at Week 1, followed by 10⁷ PFU/mL for subsequent doses; Opdivo should be IV administered starting at Week 3
Approval was based on data from an open-label, multiregional, single-arm study (IGNYTE; n=140), which enrolled adults with Stage IIIB, IIIC or IV unresectable advanced melanoma who had previously been treated with at least eight consecutive weeks of anti-PD-1 therapy, alone or combined with another anticancer therapy, immediately prior to enrollment and who had experienced disease progression while on the anti-PD-1-based therapy; 91 patients who had at least one noninjected lesion were included in the efficacy population; the objective response rate was 24.2% (95% CI, 15.8–34.3), with a median duration of response of 14.1 months (95% CI, 10.7–not reached)
Tudriqev provides an intratumor treatment option for patients with unresectable advanced melanoma who have experienced progression on a PD-1-blocking antibody; NCCN guidelines for cutaneous melanoma state that, for progression of melanoma during/shortly after adjuvant or first-line therapy, second-line agents not used during first-line treatment and from a different class should be considered; for those with progression on single-agent, anti-PD-1 checkpoint immunotherapy, reasonable treatment options include anti-PD-1/ipilimumab (Yervoy) or nivolumab/relatlimab-rmbw (Opdualag) combination immunotherapy, or a BRAF/MEK inhibitor combination for those with a BRAF V600 mutation; the tumor-infiltrating lymphocyte therapy lifileucel (Amtagvi) is also listed as another treatment option
Tudriqev will be available from Replimune; the launch timeframe is to be determined (TBD)

July 9, 2026 — isatuximab-irfc (Sarclisa Escena)

BLA approval; Assessment Aid and Orphan Drug designations; new SC formulation of IV isatuximab-irfc (Sarclisa); approved for all existing indications of IV Sarclisa; Sarclisa Escena and IV Sarclisa have different dosages and routes of administration
CD38-directed cytolytic antibody
Indicated (1) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor; (2) in combination with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received 1–3 prior lines of therapy; and (3) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
Solution for injection: 1,400 mg/10 mL (140 mg/mL) in a single-dose vial
Recommended dosage is given SC by an HCP with the CirCLIQ on-body delivery system or with a syringe and infusion set for manual administration; administered weekly in combination with pomalidomide and dexamethasone for a 28-day cycle (Cycle 1), then every two weeks (Cycle 2 and beyond); or weekly in combination with carfilzomib and dexamethasone for a 28-day cycle (Cycle 1), then every two weeks (Cycle 2 and beyond); or weekly in combination with bortezomib, lenalidomide and dexamethasone for a 28-day cycle (Cycle 1), then every two weeks for Cycles 2–12 and every four weeks for Cycle 13 and beyond; continued until disease progression or unacceptable toxicity; premedicate with dexamethasone, a leukotriene receptor antagonist, acetaminophen and diphenhydramine
Sarclisa Escena is available from Sanofi

July 24, 2026 — bevacizumab-vikg (Lytenava)

BLA approval; first FDA-approved ophthalmic bevacizumab formulation for the treatment of neovascular (wet) age-related macular degeneration (nAMD)
Vascular endothelial growth factor (VEGF) inhibitor
Indicated for the treatment of patients with nAMD
Solution for injection: 1.25 mg (0.05 mL of 25 mg/mL) in a single-dose vial
Recommended dosage is administered by intravitreal injection once monthly (approximately every 28 days) by a qualified physician
Lytenava will be available from Outlook Therapeutics before the end of 2026

July 24, 2026 — insulin aspart-fsan (Garzulys)

BLA approval; 10 mL (100 units/mL) injection in a multidose vial for SC or IV use and 3 mL (100 units/mL) single-patient-use prefilled pen for SC use have received FDA approval as biosimilar to the same presentations of insulin aspart (Novolog)
Garzulys is approved for the same indication as reference drug Novolog: to improve glycemic control in adults and pediatric patients with diabetes mellitus
Garzulys will be available from Meitheal Pharmaceuticals; the launch timeframe is TBD

July 10, 2026 — enfortumab vedotin-ejfv (Padcev)

Astellas Pharma; nectin-4-directed antibody and microtubule inhibitor conjugate; Assessment Aid and Priority Review designations; review conducted under Project Orbis
Expanded indication: in combination with pembrolizumab (Keytruda) or pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex), as neoadjuvant treatment, and then continued after cystectomy as adjuvant treatment, for adults with muscle-invasive bladder cancer (MIBC); previously, this indication was only for those who were ineligible for cisplatin-containing chemotherapy; the approval expands use in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy
Administered as an IV infusion by an HCP; recommended dosage is weight-based; for those who are eligible for cisplatin-containing chemotherapy, Padcev is administered as neoadjuvant treatment on Days 1 and 8 of each 21-day cycle for four cycles or until disease progression precluding curative-intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on Days 1 and 8 of each 21-day cycle for five cycles or until disease recurrence or unacceptable toxicity
Other indications are detailed in the product label

July 10, 2026 — pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex)

Merck Sharp & Dohme; pembrolizumab is a PD-1-blocking antibody and berahyaluronidase alfa is an endoglycosidase; Assessment Aid and Priority Review designations; review conducted under Project Orbis
Expanded indication: in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant treatment, followed by adjuvant treatment after cystectomy in adults with MIBC; previously, this combination was approved for those who were ineligible for cisplatin-containing chemotherapy; approval extends the previously approved regimen from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy
Keytruda is administered via IV infusion by an HCP; for patients who are cisplatin-eligible, the recommended Keytruda dose for neoadjuvant treatment is given in combination with Padcev every three weeks for four doses, every six weeks for two doses, or until disease progression precluding curative-intent cystectomy or unacceptable toxicity; in the adjuvant phase, Keytruda is administered in combination with Padcev every three weeks for 13 doses, every six weeks for seven doses, or until disease recurrence or unacceptable toxicity; administer Keytruda after Padcev when given on the same day
Keytruda Qlex is given as an SC injection by an HCP; for patients who are cisplatin-eligible, the recommended dose in the neoadjuvant setting is given in combination with Padcev every three weeks for four doses, every six weeks for two doses, or until disease progression precluding curative-intent cystectomy or unacceptable toxicity; in the adjuvant setting, the recommended dose is given in combination with Padcev every three weeks for 13 doses, every six weeks for seven doses, or until disease recurrence or unacceptable toxicity; administer Keytruda Qlex after Padcev when given on the same day
Other indications are detailed in the product label

July 31, 2026 — lutetium Lu 177 vipivotide tetraxetan (Pluvicto)

Novartis Pharmaceuticals; radioligand therapeutic agent; Assessment Aid designation; review conducted under Project Orbis
New indication: in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer; patients should be selected for treatment using gallium Ga 68 gozetotide (Locametz) or another approved PSMA positron emission tomography (PET) scan product, based on PSMA expression in tumors
Administered IV by an HCP every six weeks for six doses; continued until disease progression or unacceptable toxicity; as this product is a radiopharmaceutical, proper safety measures should be followed to minimize exposure to radiation
Other indication: treatment of adults with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy and (1) are considered appropriate to delay taxane-based chemotherapy, or (2) have received prior taxane-based chemotherapy

Traditional

July 15, 2026 — enlicitide (Lipfendra)

NDA approval; Commissioner’s National Priority Voucher (CNPV) pilot program and Priority Review designations; first FDA-approved oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
PCSK9 inhibitor
Indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH); cardiovascular (CV) outcomes trials have demonstrated that decreasing LDL-C decreases the risk of major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy
Oral tablets: 20 mg
Recommended dosage is taken orally once daily on an empty stomach in the morning, with water, black coffee or plain tea; patients should wait at least 30 minutes before eating food or drinking any other beverages
Approval was based on data from two randomized, double-blind, placebo-controlled clinical trials (CORALreef Lipids, n=2,909; CORALreef HeFH, n=303); CORALreef Lipids included adults with a history of a major atherosclerotic cardiovascular disease (ASCVD) event with an LDL-C level of ≥55 mg/dL and patients at risk for a first ASCVD event with an LDL-C level of ≥70 mg/dL; CORALreef HeFH included adults with HeFH currently taking a moderate- or high-intensity statin with an LDL-C level of ≥55 mg/dL and a history of a major ASCVD event or an LDL-C level of ≥70 mg/dL without a history of major ASCVD; the primary endpoint of both studies was the mean percentage change in LDL-C from baseline to Week 24 with enlicitide compared with placebo; in CORALreef Lipids the mean percentage change in LDL-C at Week 24 was -57.1% (95% CI, -61.8 to -52.5) for enlicitide compared with 3% (95% CI, 0.9−5.1) for placebo (adjusted between-group difference, -55.8%; 95% CI, -60.9 to -50.7; P<0.001); in CORALreef HeFH, the mean percentage change in LDL-C at Week 24 was -58.2% for enlicitide compared with 2.6% for placebo (between-group difference, -59.4%; 95% CI, -65.6% to -53.2%; P<0.001)
Other FDA-approved PCSK9 inhibitors are injected SC and include the following agents: alirocumab (Praluent), evolocumab (Repatha) and lerodalcibep-liga (Lerochol); all three of these agents carry the same indication as Lipfendra; Repatha and Praluent carry additional MACE-reduction indications and are also indicated for homozygous familial hypercholesterolemia (HoFH) in adults (Praluent) and in patients ≥10 years of age (Repatha); both agents are also indicated for HeFH in pediatric patients (Repatha: ≥10 years of age; Praluent: ≥8 years of age); Lipfendra is being evaluated in an ongoing clinical study assessing its impact on CV morbidity and mortality
Lipfendra is available from Merck Sharp & Dohme

July 24, 2026 — centanafadine (Simtriyo)

NDA approval; Priority Review designation; first FDA-approved norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI)
NDSRI and central nervous system (CNS) stimulant
Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients ≥6 years of age weighing ≥20 kg; not recommended in pediatric patients <6 years of age because of a higher incidence of weight loss; not recommended in pediatric patients weighing <20 kg due to lack of data in these patients and risk of weight loss
Extended-release capsules: 140 mg, 210 mg and 280 mg
Recommended dosage is taken orally once daily in the morning, with or without food, at approximately the same time each day; capsules can be swallowed whole or opened and sprinkled in applesauce, yogurt or orange juice; dosage is based on the patient’s age: 6–12 years of age (weight-based), 13–17 years of age (280 mg) or adults (210 mg–280 mg)
Boxed warnings for suicidal ideation and behaviors in pediatric patients ≥6 years of age and for abuse, misuse and addiction
Approval was based on data from four randomized, double-blind, placebo-controlled Phase 3 clinical trials; the first study (n= 480) included pediatric patients 4–12 years of age (only indicated for ≥6 years of age) and evaluated the primary endpoint of change from baseline at Week 6 in symptoms total raw score on the ADHD Rating Scale-5 (ADHD-RS-5; higher scores reflect more severe symptoms); for patients 6–12 years of age, centanafadine demonstrated a statistically significant improvement compared with placebo (treatment difference, -5.6; 95% CI, -8.78 to -2.33) in the primary endpoint; the second study (n= 459) was conducted in adolescents 13–17 years of age and demonstrated statistically significant improvements at Week 6 in the ADHD-RS-5 symptoms total raw score compared with placebo (P=0.0006) in the higher-dose centanafadine group (328.8 mg) but not in the lower-dose centanafadine group (164.4 mg); studies 3 (n=466) and 4 (n=440) evaluated adults 18–55 years of age for the primary endpoint of Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at Day 42; centanafadine resulted in statistically significant improvements in the least-squares mean differences in AISRS total score compared with placebo in both studies for all doses
FDA-approved therapies for ADHD include stimulants (e.g., amphetamine, amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, lisdexamfetamine, methamphetamine, methylphenidate, serdexmethylphenidate/dexmethylphenidate) and nonstimulants, including the selective norepinephrine reuptake inhibitors atomoxetine (Strattera) and viloxazine (Qelbree), as well as the centrally acting alpha-2 adrenergic agonists clonidine (Onyda XR) and guanfacine (Intuniv)
Simtriyo will be available from Otsuka later in 2026; launch is expected following controlled substance classification from the Drug Enforcement Administration (DEA)

Aug. 5, 2026 — oveporexton (Orzeyful)

NDA approval; Breakthrough Therapy, Orphan Drug and Priority Review designations; first FDA-approved therapy to directly target the underlying loss of orexin activity in narcolepsy type 1 (narcolepsy with cataplexy)
Orexin receptor 2 (OX2R) agonist
Indicated for the treatment of narcolepsy type 1 in adults
Oral tablets: 0.5 mg, 1 mg and 2 mg
Recommended dosage is taken orally upon awakening, followed by a second dose 3–5 hours later; can be taken with or without food
Approval was based on data from two Phase 3, randomized, multicenter, double-blind, placebo-controlled, 12-week, parallel-group studies (FirstLight and RadiantLight) that evaluated 273 adults with narcolepsy type 1; oveporexton demonstrated statistically significant improvements in the change from baseline to Week 12 in mean sleep latency from the maintenance of wakefulness test (primary endpoint); in Study 1, the least squares mean change difference from placebo with oveporexton 1 mg twice daily was 13.8 minutes (95% CI, 10.2–17.4) and 17.2 minutes (95% CI, 13.7–20.7) with oveporexton 2 mg twice daily; in Study 2, the least squares mean change difference from placebo was 20.1 minutes (95% CI, 16.6–23.6) with oveporexton 2 mg twice daily
According to the 2021 American Academy of Sleep Medicine (AASM) clinical practice guideline on central disorders of hypersomnolence, strongly recommended treatments for narcolepsy in adults include modafinil (Provigil; C-IV), the histamine-3 (H3) receptor antagonist/inverse agonist pitolisant (Wakix), a CNS depressant sodium oxybate (Lumryz, Xyrem, Xywav; C-III) or the dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol (Sunosi; C-IV) and conditionally recommended potential treatments include armodafinil (Nuvigil; C-IV) and the CNS stimulants dextroamphetamine and methylphenidate (both C-II); Orzeyful is a first-in-class OX2R treatment that directly targets the underlying pathophysiological cause of narcolepsy type 1
Orzeyful will be available from Takeda; launch is expected following controlled substance classification from the DEA, which is expected within 90 days of approval

Aug. 5, 2026 — influenza vaccine, mRNA (mFlusiva)

BLA approval; Accelerated Approval; first FDA-approved messenger RNA (mRNA)-based influenza vaccine
Vaccine for active immunization
Indicated for the prevention of influenza disease caused by influenza virus subtypes A and B represented in the vaccine; approved for use in persons ≥50 years of age; Accelerated Approval was granted for persons ≥65 years of age based on immune response (continued approval for this patient population may require demonstration of benefit in a confirmatory clinical trial)
Injectable suspension: 0.38 mL
Recommended dosage is a single intramuscular (IM) dose administered by an HCP
Approval was based on data from a randomized, double-blind, active-controlled Phase 3 clinical study evaluating trivalent mRNA-1010 (investigational name for mFlusiva; n=20,179) compared with a licensed standard-dose inactivated seasonal influenza vaccine (Fluarix; n=20,124) in persons ≥50 years of age; the primary endpoint was relative vaccine efficacy evaluated based on reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed, protocol-defined influenza-like illness caused by influenza A or B from at least 14 days postvaccination until the end of influenza season; at a median follow-up of 181 days, the primary endpoint occurred in 2% of mRNA-1010 recipients compared with 2.8% of recipients who received the standard-dose comparator, corresponding with a relative vaccine efficacy of 26.6% (95% CI, 16.7–35.4) and meeting the criteria for noninferiority and superiority; the immunogenicity and safety of mRNA-1010 in persons ≥65 years of age was evaluated in a randomized, double-blind, active-controlled Phase 3 study; a quadrivalent formulation of mRNA-1010 (n=1,425) was compared to a high-dose inactivated influenza vaccine comparator (Fluzone High-Dose Quadrivalent; n=1,409); all coprimary immunogenicity endpoints were met for the mRNA-1010, and a postmarketing trial in this age group will be conducted for confirmation of clinical benefit
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends all persons ≥6 months of age who do not have contraindications receive an age-appropriate influenza vaccine annually; ACIP recommends that adults ≥65 years of age preferentially receive a high-dose inactivated, adjuvanted inactivated or recombinant vaccine, if available; mFlusiva provides a novel, non-egg-based option for influenza prevention in adults ≥50 years of age
mFlusiva is expected to be available from ModernaTx for the 2026–2027 respiratory virus season

July 28, 2026 — norelgestromin/ethinyl estradiol transdermal system (Gwyn Lo)

505(b)(2) NDA approval; Gwyn Lo provides a once weekly, low-dose estrogen contraceptive patch
Progestin/estrogen combination hormonal contraceptive
Indicated for the prevention of pregnancy in women with a BMI <30 kg/m² for whom a combined hormonal contraceptive is appropriate
Transdermal system (TDS): 220 mcg/day norelgestromin and 20 mcg/day ethinyl estradiol
Recommended dosage is administered in a 28-day (four-week) cycle, with a new TDS applied to the upper outer arm, abdomen, buttock or back each week for three weeks (21 total days); Week 4 a TDS is not applied; only one TDS should be worn at a time and a new TDS should be applied on the same day of the week
Gwyn Lo will be available from Viatris Specialty later in 2026

July 29, 2026 — clonidine hydrochloride (HCl) oral solution (Qlonilik)

505(b)(2) NDA approval; clonidine HCl oral solution is also available in a 0.02 mg/mL strength (Javadin) from Azurity; Javadin is also indicated for the treatment of hypertension in adults
Central alpha-2 adrenergic agonist
Indicated for the treatment of hypertension, to lower blood pressure in adults; lowering blood pressure decreases the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions (MIs); Qlonilik may be used alone or concurrently with other antihypertensive agents
Oral solution: 0.05 mg/mL
Recommended dosage is individualized based on response and is taken orally twice daily (morning and bedtime, with either an equal or higher split dosage taken at bedtime); titrated in increments of 0.1 mg per day at weekly intervals as needed
Qlonilik will be available from CMP Pharma; launch timeframe is TBD

July 7, 2026 — olopatadine HCl and mometasone furoate monohydrate nasal spray (Ryaltris)

Glenmark Pharmaceuticals; combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid
Expanded indication: treatment of symptoms of seasonal allergic rhinitis to include pediatric patients 6–11 years of age; previously approved for patients ≥12 years of age for this indication
Administered for pediatric patients 6–11 years of age as one spray in each nostril twice daily

First generic drug launches

July 13, 2026 — tapentadol HCl oral solution (Nucynta)

Novitium/ANI Pharmaceuticals launched an oral solution (20 mg/mL) generic to Collegium Pharmaceutical’s Nucynta
Opioid analgesic
Indicated for the management in adults of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Recommended dosage is individualized based on the patient’s cause and severity of pain, past analgesic treatment, and risk factors for addiction, abuse and misuse; dosed every 4–6 hours as needed for pain; use the lowest dose possible that provides sufficient analgesia; the dose should be titrated based on individual patient response to the initial dose
Annual sales for Nucynta in 2025 are not available

July 15, 2026 — oxymetazoline HCl (Rhofade)

Sun Pharmaceuticals launched a topical cream (1%) generic to Allergan’s/Mayne’s Rhofade
Alpha_1A adrenoceptor agonist
Indicated for the topical treatment of persistent facial erythema associated with rosacea in adults
Recommended dosage is to apply a pea-sized amount once daily in a thin layer to cover the entire face
Annual sales for Rhofade in 2025 were $26 million (M)

July 24, 2026 — metformin HCl/sitagliptin phosphate (Janumet XR)

PH Health launched an oral extended-release tablet (500 mg/50 mg, 1,000 mg/50 mg and 1,000 mg/100 mg) generic to Merck Sharp & Dohme’s Janumet XR
Combination of sitagliptin, a DPP-4 inhibitor, and metformin HCl, a biguanide
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM
Recommended dosage is taken orally once daily with a meal; dosage should be individualized based on the patient’s current regimen, effectiveness and tolerability
Annual sales for Janumet XR in 2025 were $360M

July 27, 2026 — rifapentine (Priftin)

Macleods Pharmaceuticals launched oral tablets (150 mg) generic to Sanofi-Aventis’ Priftin
Rifamycin antimycobacterial drug
Indicated (1) in patients ≥12 years of age for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis, in combination with one or more antituberculosis drugs to which the isolate is susceptible, and (2) for the treatment of latent tuberculosis infection caused by M. tuberculosis, in combination with isoniazid, in patients ≥2 years of age at high risk of progression to TB disease
Recommended dosage is based on body weight and should be used for active pulmonary TB in a regimen that has an initial two-month phase, followed by a four-month continuation phase; during the initial phase, rifapentine is dosed twice weekly as directly observed therapy — with no less than 72 hours between doses — given in combination with other antituberculosis drugs; during the continuation phase, rifapentine is dosed once weekly as directly observed therapy with isoniazid or another appropriate antituberculosis agent; for latent TB infection, rifapentine is administered in combination with isoniazid once weekly for 12 weeks as directly observed therapy
Annual sales for Priftin in 2025 are less than $10M

July 30, 2026 — dextromethorphan hydrobromide/quinidine sulfate (Nuedexta)

Sun Pharmaceutical Industries launched oral capsules (20 mg/10 mg) generic to Avanir Pharmaceuticals’ Nuedexta
Combination of dextromethorphan hydrobromide, an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 agonist, and quinidine sulfate, a cytochrome P450 (CYP) 2D6 inhibitor
Indicated for the treatment of pseudobulbar affect (PBA)
Recommended starting dosage is taken orally once daily for seven days; taken every 12 hours after seven days
Annual sales for Nuedexta in 2025 were $222M

AAP American Academy of Pediatrics

AASM American Academy of Sleep Medicine

ACIP Advisory Committee on Immunization Practices
ACP American College of Physicians

ADHD attention-deficit/hyperactivity disorder

ADHD-RS-5 ADHD Rating Scale-5

AISRS adult ADHD Investigator Symptom Rating Scale
ARPI androgen receptor pathway inhibitor
ASCT autologous stem cell transplant
ASCVD atherosclerotic cardiovascular disease
BLA Biologics License Application

BMI body mass index

BRAF B-Raf proto-oncogene, serine/threonine kinase

C- controlled substance classification

CBER Center for Biologics Evaluation and Research
CD cluster of differentiation
CDC Centers for Disease Control and Prevention

CDER Center for Drug Evaluation and Research

CDK cyclin-dependent kinase

CHEST American College of Chest Physicians
CI confidence interval

CKD chronic kidney disease
CNPV Commissioner's National Priority Voucher

CNS central nervous system
COVID-19 coronavirus disease 2019
CV cardiovascular

CYP cytochrome P450

DEA Drug Enforcement Administration

DNRI dopamine and norepinephrine reuptake inhibitor

DPP-4 dipeptidyl peptidase-4

EO Executive Order

ER estrogen receptor
FDA Food and Drug Administration
GLP-1 glucagon-like peptide-1

GLP-1s glucagon-like peptide-1 receptor agonists
H1 histamine-1
H3 histamine-3

HCl hydrochloride
HCP healthcare professional

HeFH heterozygous familial hypercholesterolemia
HER2 human epidermal growth factor receptor 2
HHS Department of Health and Human Services

HoFH homozygous familial hypercholesterolemia
HR hormone receptor
ICER Institute for Clinical and Economic Review
ILD interstitial lung disease
IM intramuscular
IV intravenous

IVAC International Vaccine Access Center

LDL-C low-density lipoprotein cholesterol
M million

mAbs monoclonal antibodies

MACE major adverse cardiovascular events

mAPMN/S metastatic androgen pathway modulation-naïve or -sensitive

MEK mitogen-activated protein kinase kinase

MI myocardial infarction

MIBC muscle-invasive bladder cancer

MMR measles, mumps and rubella

MOU Memorandum of Understanding

mRNA messenger ribonucleic acid

nAMD neovascular (wet) age-related macular degeneration

NCCN National Comprehensive Cancer Network
NDA New Drug Application

NDSRI norepinephrine-dopamine-serotonin reuptake inhibitor

NMDA N-methyl-D-aspartate

NSCLC non-small cell lung cancer
OSA obstructive sleep apnea

OX2R orexin receptor 2 agonist

PBA pseudobulbar affect

PCSK9 proprotein convertase subtilisin/kexin type 9
PD-1 programmed cell death protein 1

PET positron emission tomography

PFS progression-free survival

PFU plaque-forming units
PIK3CA phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

PR progesterone receptor

PSMA prostate-specific membrane antigen
RA rheumatoid arthritis

RNA ribonucleic acid

ROS1 ROS proto-oncogene 1, receptor tyrosine kinase

RTOR Real-Time Oncology Review

RT-PCR reverse transcriptase-polymerase chain reaction
SC subcutaneous
SGLT2 sodium-glucose cotransporter-2
T2DM type 2 diabetes mellitus

TB tuberculosis

TBD to be determined
TDS transdermal system
TMP-SMX trimethoprim-sulfamethoxazole

U.S. United States

VEGF vascular endothelial growth factor

Editor-in-Chief: Maryam Tabatabai, PharmD

Executive Editor: Anna Schreck Bird, PharmD

Deputy Editors: Nicole Kjesbo, PharmD, BCPS; Olivia Pane, PharmD, CDCES

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition, or if you need medical advice, please contact your healthcare provider.
All brand names are property of their respective owners.

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