publications

The American Academy of Pediatrics (AAP) published the 2026 recommended childhood and adolescent immunization schedule for the U.S. The 2026 recommendations remain mostly unchanged from previous guidance released by AAP in August 2025. The schedule has been formally endorsed by 12 medical and health care organizations: American Academy of Family Physicians (AAFP), American College of Nurse Midwives (ACNM), American College of Obstetricians and Gynecologists (ACOG), American Medical Association (AMA), American Pharmacists Association (APhA), Council of Medical Specialty Societies (CMSS), Infectious Diseases Society of America (IDSA), National Association of Pediatric Nurse Practitioners (NAPNAP), National Medical Association (NMA), Pediatric Infectious Diseases Society (PIDS), Pediatric Pharmacy Association (PPA) and Society for Adolescent Health and Medicine (SAHM). The AAP continues to recommend routine vaccination for 18 diseases, including respiratory syncytial virus (RSV), hepatitis A, hepatitis B, rotavirus, influenza and meningococcal disease. These recommendations differ from the schedule released by the Centers for Disease Control and Prevention (CDC) in January 2026 which recommends RSV, hepatitis A, hepatitis B and meningococcal disease only for certain high-risk groups/populations and recommends rotavirus, coronavirus disease 2019 (COVID-19), influenza, meningococcal disease, hepatitis A and hepatitis B vaccines based on shared clinical decision-making between parents and health care professionals (HCPs). AAP states the organization no longer endorses the vaccination schedule from the CDC.

The AAP affirms that its vaccine schedule is grounded in established evidence evaluation, vaccine safety data, disease epidemiology in the U.S. and assessments of vaccines’ preventive benefits. As RSV is a leading cause of hospitalization for infants, the AAP maintains that although the CDC recommends the vaccine only for high-risk groups/populations, most infants should receive it if the pregnant parent did not receive a maternal RSV vaccine. AAP reiterates that the hepatitis B vaccine has received extensive testing for safety and efficacy and is highly effective in preventing newborn infection when administered within 24 hours of birth as well as preventing acute and chronic liver disease. Prior to introduction of the rotavirus vaccine, 40,000 infants and young children were hospitalized annually with severe diarrhea and vomiting due to rotavirus. More than 80% of pediatric deaths associated with influenza have occurred in unvaccinated or partially vaccinated children. Children < 5 years of age, and especially those < 2 years of age, are at high risk for severe illness/hospitalization from influenza. In addition to the vaccination schedule, AAP has published a corresponding policy statement as well as a parent-friendly version of the schedule and a Q&A on differences between the AAP recommendations and other vaccine schedules.

The American College of Obstetricians & Gynecologists (ACOG) published a committee statement on maternal immunization. Obstetrician–gynecologists (OB-GYNs) and other professionals involved in obstetric care are advised to consistently evaluate the vaccination status of their pregnant patients as part of routine clinical practice. These HCPs should advise and, when feasible, give vaccines to pregnant patients. Specific recommendations are provided by ACOG for use of the following vaccines in pregnancy: COVID-19, influenza, RSV and Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis).

The FDA is requesting that manufacturers remove information on the risk of suicidal ideation and behavior from the labeling of glucagon-like peptide-1 (GLP-1) receptor agonists that currently include this language: liraglutide (Saxenda), semaglutide (Wegovy) and tirzepatide (Zepbound). FDA has conducted a comprehensive review and did not find an increased risk of suicidal ideation and behavior associated with the use of GLP-1s.
A systematic review and meta-analysis published in BMJ found an average rate of weight regain of 0.4 kg monthly after cessation of weight management medications in adults with overweight/obesity, with patients projected to return to baseline weight within 1.7 years on average. The review included 37 studies (trials and cohort studies) with 9,341 participants and an average treatment duration of 39 weeks, with average follow up of 32 weeks. Patients in the intervention arm received pharmacological therapies that are currently or were previously approved for weight loss; the comparator arm was behavioral weight management programs. Cardiometabolic factors (e.g., hemoglobin A1C [HbA1C], fasting glucose, total cholesterol, triglycerides, blood pressure) were projected to return to baseline within 1.4 years after medication cessation.
The FDA plans to implement measures to restrict GLP-1 receptor agonist active pharmaceutical ingredients (APIs) that are intended for use in non-FDA-approved compounded medications. These APIs are currently being widely marketed by certain companies (such as Hims & Hers) as alternative options to FDA-approved drugs. The Agency is working to address misleading direct-to-consumer advertising and marketing. Companies are not allowed to claim that compounded products, which are not FDA-approved, are generic versions of FDA-approved drugs, have the same active ingredient as FDA-approved drugs or are clinically proven to provide results for patients.

The Agency has sent safety labeling change notification letters to manufacturers of the following influenza vaccines: Afluria, Fluarix, Flucelvax, Flulaval, Flumist and Fluzone. The letters request addition of new safety information to the labeling for influenza vaccines with an approved indication extending to less than 5 years of age. The request is for addition of a new Warning/Precaution regarding febrile seizures and corresponding updates to the postmarketing experience adverse drug reactions (ADR) section with related data.
The FDA in collaboration with the European Medicines Agency (EMA) has developed guiding principles related to the drug development cycle for industry/developers to consider when using artificial intelligence (AI) for product development. The 10 principles include (1) human-centric by design, (2) risk-based approach, (3) adherence to standards, (4) clear context for use, (5) multidisciplinary expertise, (6) data governance and documentation, (7) model design and development practices, (8) risk-based performance evaluation, (9) life cycle management and (10) clear, essential information.
The FDA has announced additional flexibilities for overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). This enhanced flexibility aids in expediting product development.
The Agency previously communicated risks related to use of capecitabine and fluorouracil (5-FU) in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Previously, the FDA advised discussing testing for DPD deficiency with patients due to the potential for serious and life-threatening toxicities in these patients. The Agency is now recommending that all patients be tested for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.

Labeling was updated to change the trade name of Rybelsus R2 formulation (semaglutide) to Ozempic (semaglutide) tablets. Rybelsus tablets will be available in 3 mg, 7 mg and 14 mg strengths (formerly known as R1 formulation), while Ozempic tablets will be available in 1.5 mg, 4 mg and 9 mg strengths (formerly known as R2 formulation). Ozempic tablets have enhanced bioavailability allowing comparable therapeutic levels as the originally approved 3 mg, 7 mg and 14 mg Rybelsus tablets. Both Rybelsus and Ozempic tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) and to reduce the risk of MACE (e.g., cardiovascular [CV] death, non-fatal myocardial infarction [MI], non-fatal stroke) in adults with T2DM who are at high risk for these events. Before the launch in the second quarter of 2026, Novo Nordisk will inform patients, caregivers and HCPs about what to anticipate at the pharmacy.
ASHP has published a summary of national drug shortage statistics from January 2001 to December 2025. There are currently 216 active drug shortages which is substantially less than the all-time high of 323 shortages which occurred in the first quarter of 2024. Furthermore, long-standing shortages are resolving, with 75% of active shortages starting in 2022 or later. While overall shortages have decreased, a single shortage can still affect many patients.
ASHP and FDA are reporting bacitracin 3.5 g ophthalmic ointment from Padagis is unavailable due to discontinuation of the manufacture of the drug. The product is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by bacitracin-susceptible organisms. The manufacturer temporarily discontinued this product in July 2024; the shortage was first reported by the FDA in March 2025. Other generic versions of the ophthalmic ointment are also no longer commercially available; product is expected to be available again in October 2026.
The FDA is continuing to report shortages of penicillin G benzathine (Bicillin L-A). The 2,400,000 IU/4 mL and 1,200,000 IU/2 mL strengths have limited availability and the 600,000 IU/mL strength is unavailable with next delivery and estimated recovery in December 2026. Non-FDA approved benzathine benzylpenicillin tetrahydrate (Lentocilin), from Portugal, remains available through temporary importation.
An evidence-based review process to evaluate vaccine safety and effectiveness for the 2026–2027 respiratory virus season has been initiated by the Vaccine Integrity Project in collaboration with the AMA. Immunizations for influenza, COVID-19 and RSV will be assessed.
Valneva, the manufacturer of chikungunya vaccine, live (Ixchiq), has announced voluntary withdrawal of the Biologics License Application (BLA) and Investigational New Drug (IND) for the vaccine. This withdrawal follows suspension of its license by the FDA in August 2025. Currently, there are no clinical trials actively vaccinating patients with Ixchiq. For more details on the safety concerns with Ixchiq, view the August edition of Prime’s Trending Topics & Drug Approvals.
The U.S. Department of Health and Human Services (HHS) and the U.S. Department of State announced the U.S. has completed its withdrawal from the World Health Organization (WHO). The departure was attributed to concerns regarding WHO’s management of the COVID-19 pandemic, lack of adoption for urgently needed reforms and issues related to demonstrating independence from undue political influence by WHO member states.
As of Feb. 20, 2026, the CDC announced that the amount of acute respiratory illness resulting in people seeking health care is moderate. Influenza activity remains elevated across the U.S. with influenza A activity decreasing while influenza B activity is increasing nationally. RSV activity is elevated and increasing in some parts of the U.S. COVID-19 is decreasing overall but remains elevated in some parts of the U.S. The CDC reports influenza-like illness (ILI) for the week ending February 14, 2026 (week 6). Influenza A(H3N2) continues to be the most frequently reported influenza virus. ASHP is reporting shortages of the antiviral oseltamivir (Tamiflu).  
The CDC reports, as of Feb. 19, 2026, that there have been 982 confirmed cases of measles in the U.S. in 2026. Cases include, 25% in individuals < 5 years of age, 59% in those 5 to 19 years of age, 15% in those ≥ 20 years of age and 1% with unknown age; 94% of cases are among individuals with unvaccinated or unknown vaccination status. Johns Hopkins' Bloomberg School of Public Health is monitoring the measles outbreak in real-time through their International Vaccine Access Center (IVAC). On Feb. 20, 2026, IVAC reported 3,309 total cases in the U.S. in the prior 12 months. CMS administrator, Dr. Mehmet Oz, urged Americans to get vaccinated against measles as cases rise in the U.S.

The American College of Chest Physicians (CHEST) has published a clinical practice guideline on biologic management in severe asthma for adults. This new guideline provides seven evidence-based recommendations for pulmonologists, allergists and immunologists caring for severe asthma patients.
The American Gastroenterological Association (AGA) has published a clinical practice update (expert review) on evaluating and managing refractory constipation (RC). As RC is relatively rare, part of the diagnostic process is to ensure patients have undergone sufficient trials of OTC and Rx meds and non-drug therapies including combinations of these agents.
A Research Letter published in JAMA details leading cancer deaths in those < 50 years of age in the U.S. Data from the National Center for Health Statistics were used to assess changes in cancer mortality for the five leading cancer-related deaths over the past three decades.
The Journal of the American College of Cardiology (JACC) has published an inaugural report on CV risk factors (hypertension, diabetes, obesity, cholesterol and cigarette smoking) and the five conditions that collectively represent most CV deaths and disability in the U.S. Coronary heart disease, acute MI, heart failure, peripheral artery disease and stroke collectively are responsible for most CV deaths and disability. Long-term improvements in mortality are slowing/reversing and health disparities as well as quality of care gaps persist.
The Institute for Clinical and Economic Review (ICER) has released the final evidence report on the clinical effectiveness and value of cytisinicline (investigational) compared to varenicline for smoking cessation. The panel concluded that for people who smoke cigarettes, current evidence is adequate to demonstrate a net health benefit of cytisinicline over behavioral support alone; however, the current evidence is inadequate to demonstrate that the net health benefit of cytisinicline with behavioral support is greater than varenicline with behavioral support.

Drug Approvals

Specialty

Jan. 12, 2026 – copper histidinate (Zycubo)

New Drug Application (NDA) approval; first treatment for children with Menkes disease; Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review
Copper replacement product
Indicated for the treatment of Menkes disease in pediatric patients
Limitation of use: not indicated for the treatment of Occipital Horn Syndrome (milder form of Menkes disease)
Lyophilized powder for reconstitution: 2.9 mg copper histidinate (equivalent to 0.5 mg elemental copper) in a single-dose vial
Recommended dosage is administered as a subcutaneous (SC) injection; for pediatric patients < 1 year of age, it is injected twice daily (eight to 12 hours between injections); for patients 1 year of age to < 17 years of age, the recommended dosage is injected once daily; caregivers can administer following proper training
Approval was based on data from two open-label, single-arm clinical trials (n=48 primary efficacy analysis) that were compared to data from an untreated external control cohort; patients who received early treatment (started within four weeks of birth) with copper histidinate (n=31) exhibited a significant improvement in overall survival compared to patients in the external control-early treatment (no prior copper treatment, asymptomatic for significant neurological manifestations at about four weeks after birth) cohort (n=17) with a 78% reduction in the risk of death (hazard ratio, 0.22; 95% confidence interval, 0.1 to 0.49); the median survival time in the copper histidinate arm was 177.1 months compared with 17.6 months in the external control arm
Menkes disease is a rare X-linked recessive neurodegenerative disorder predominantly affecting males; it is caused by a genetic mutation that leads to impaired copper absorption; it is characterized by seizures, early birth, delays in meeting developmental milestones, kinky and/or steely colored hair; abnormalities occur throughout the body in the vascular, renal, gastrointestinal, muscular and nervous systems; 90% of Menkes patients develop symptoms in infancy and do not survive beyond three years of age; Zycubo provides copper replacement in a SC formulation that bypasses the genetic defect in intestinal absorption; daily injections with copper histidinate, if initiated within a month of birth, are most effective and may prolong survival; other treatments are symptomatic
Zycubo is available from Sentynl

Nov. 25, 2025 – sibeprenlimab-szsi (Voyxact)

BLA approval; Accelerated Approval, Breakthrough Therapy, Priority Review
A proliferation inducing ligand (APRIL) blocker
Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression; Accelerated Approval based on reduction in proteinuria; not established whether slows kidney function decline over the long-term; continued approval may require demonstration of benefit in a confirmatory clinical trial
Solution for injection: 400 mg/2 mL (200 mg/mL) in a single-dose prefilled syringe
Recommended dosage is given as a subcutaneous (SC) injection once every four weeks; patients/caregivers can administer following proper training
Approval was based on a randomized, double-blind, placebo-controlled trial (VISIONARY; n=320 in prespecified interim analysis) that demonstrated the relative change from baseline in the urine protein/creatinine ratio based on 24-hour urine collections (uPCR-24h) at month nine was significantly improved with sibeprenlimab-szsi compared to placebo (difference in estimated percent change of 51% versus placebo; p<0.001)
Other FDA-approved therapies for IgAN include (1) the corticosteroid budesonide (Tarpeyo), a delayed release oral corticosteroid indicated to reduce the loss of kidney function in adults at risk for disease progression, (2) sparsentan (Filspari), an oral endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults at risk for disease progression and both (3) iptacopan (Fabhalta), an oral complement factor B inhibitor, and (4) atrasentan (Vanrafia), an oral endothelin receptor antagonist, which are indicated to reduce proteinuria in adults at risk for disease progression (Accelerated Approval for both)
Voyxact is available from Otsuka

Dec. 9, 2025 – etuvetidigene autotemcel (Waskyra)

BLA approval; Orphan Drug, Rare Pediatric Disease, Regenerative Medicine Advanced Therapy
Autologous hematopoietic stem cell (HSC)-based gene therapy
Indicated for the treatment of pediatric patients ≥ 6 months of age and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available
Suspension for injection: packaged in one to eight infusion bags containing a suspension of 2 to 11.4 x 10⁶ cells/mL (1.9 to 11.4 x 10⁶ CD34+ cells/mL) in a cryopreservative solution; for autologous use only (patients undergo hematopoietic stem and progenitor cell mobilization followed by apheresis to obtain CD34+ cells for manufacturing of the product)
Recommended dosage is a minimum of 7 x 10⁶ CD34+ cells per kg administered IV by an HCP; reduced-intensity conditioning is required prior to the infusion
Approval was based on two open-label, single-arm, multinational clinical studies and an expanded access program (n=27 total); etuvetidigene autotemcel demonstrated a reduction in the rate of severe infections from two infections per patient year observation (PYO) in the 12 months pre-treatment to 0.2 per PYO in the six to 18 months post-gene therapy; the rate of moderate and severe bleeding events also decreased from two events per PYO in the 12 months pre-treatment to 0.8 events per PYO in the 12 months after treatment
Prior to approval of Waskyra, patients with WAS received symptomatic management and allogeneic HSCT which required a matched donor; Waskyra is the first gene therapy for WAS and is prepared from modification of the patient’s own HSC genetically modified to include functional copies of the WAS gene
Waskyra is expected to be available from Fondazione Telethon with timeframe to be determined (TBD)

Dec. 16, 2025 – depemokimab-ulaa (Exdensur)

BLA approval; first ultra-long-acting biologic with twice per year dosing for patients with severe asthma with an eosinophilic phenotype
Interleukin-5 (IL-5) antagonist
Indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age; not indicated for relief of acute bronchospasm or status asthmaticus
Solution for injection: 100 mg/mL in a single-dose prefilled pen and single-dose prefilled syringe with needle guard
Recommended dosage is administered once every six months by SC injection into the upper arm, thigh or abdomen by an HCP
Approval was based on data from two randomized, placebo-controlled phase 3 trials (SWIFT-1 and SWIFT-2; n=762 total); depemokimab-ulaa demonstrated a significant decrease in the rate of asthma attacks compared with placebo over 52 weeks (SWIFT-1: 58% reduction; SWIFT-2: 48% reduction) corresponding with rate ratios of 0.42 (p<0.001) and 0.52 (p<0.001), respectively
Other similar FDA approved agents include (1) the IL-5 receptor alpha-directed cytolytic monoclonal antibody benralizumab (Fasenra) (indicated for ≥ 6 years of age), (2) the IL-5 antagonist monoclonal antibody reslizumab (Cinqair) (indicated for ≥ 18 years of age) and (3) the IL-5 antagonist monoclonal antibody mepolizumab (Nucala) (indicated for ≥ 6 years of age)
Exdensur is available from GlaxoSmithKline

Dec. 19, 2025 – aficamten (Myqorzo)

New Drug Application (NDA) approval; Breakthrough Therapy, Orphan Drug
Cardiac myosin inhibitor
Indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms
Film-coated tablets: 5 mg, 10 mg, 15 mg, 20 mg
Recommended starting dosage is taken orally once daily with or without meals at about the same time every day; dosage is increased every two to eight weeks until a maintenance dose or the maximum dose is reached; maintenance dosage should be individualized based on echocardiographic assessments and clinical status
Approval was based on a double-blind, randomized, Phase 3 clinical trial (SEQUOIA-HCM; n=282) that evaluated the change from baseline to week 24 in peak oxygen uptake as assessed by cardiopulmonary exercise testing; at week 24, the average change in the peak oxygen uptake was 1.8 mL/kg/minute (95% CI, 1.2 to 2.3) in the aficamten-treated patients compared with 0 mL/kg/min (95% CI, -0.5 to 0.5) in the placebo group (p<0.001)
Mavacamten (Camzyos) is also a cardiac myosin inhibitor that is similarly indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III oHCM to improve functional capacity and symptoms; it also carries a boxed warning for the risk of heart failure and is supplied as oral capsules with the dosage individualized based on clinical status and echocardiographic assessment of patient response
Boxed warning for risk of heart failure
Myqorzo is available from Cytokinetics through a REMS program

Dec. 23, 2025 – mitapivat (Aqvesme)

NDA approval; first oral medication for beta-thalassemia and first FDA-approved drug for alpha-thalassemia
Pyruvate kinase activator
Indicated for the treatment of anemia in adults with alpha- or beta-thalassemia
Tablets: 100 mg
Recommended dosage is taken orally twice daily with or without food
Approval was based on two multinational, randomized, double-blind, placebo-controlled clinical trials (ENERGIZE-T; n=258 transfusion-dependent thalassemia and ENERGIZE; n=194 non-transfusion-dependent thalassemia); in ENERGIZE-T, compared to placebo, a greater proportion of mitapivat patients achieved a transfusion reduction response (defined as ≥ 50% reduction in the number of red blood cell [RBC] units transfused with a reduction of at least two units of RBCs transfused in any consecutive 12-week period) (30% versus 13%, respectively; adjusted rate difference, 18%; 95% CI, 8 to 27; p=0.0003); in ENERGIZE, 42% of patients achieved a hemoglobin response compared with 2% of placebo patients from week 12 through week 24 (least-squares mean difference, 41%; 95% CI, 32 to 50, two-sided p<0.0001)
Other FDA-approved therapies for beta-thalassemia are indicated specifically for those who require RBC transfusions; these agents include luspatercept-aamt (Reblozyl) which is an erythroid maturation agent given SC, betibeglogene autotemcel (Zynteglo) which is an autologous HSC-based gene therapy given as a one-time, single-dose IV infusion (also indicated for pediatric patients) and exagamglogene autotemcel (Casgevy) which is an autologous genome edited HSC-based gene therapy given as a one-time, single-dose IV infusion
Boxed warning for hepatocellular injury
Aqvesme will be available from Agios in late January 2026 following implementation of the corresponding REMS program

Dec. 23, 2025 – narsoplimab-wuug (Yartemlea)

BLA approval; Breakthrough Therapy, Orphan Drug, Priority Review; first FDA-approved therapy for transplant-associated thrombotic microangiopathy
Mannan-binding lectin-associated serine protease 2 (MASP-2) inhibitor
Indicated for the treatment of adult and pediatric patients ≥ 2 years of age with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
Solution for injection: 370 mg/2 mL in a single-dose vial
Recommended dosage is based on body weight once weekly given as an IV infusion over 30 minutes by an HCP; increase frequency to twice weekly if there is inadequate improvement in TA-TMA signs/symptoms
Approval was based on a single-arm, open-label study (TA-TMA; n=28) that assessed TMA response, defined as clinical improvement in laboratory markers of TMA (platelets and lactate dehydrogenase) and either organ function improvement or freedom from transfusions; 61% of patients achieved a TMA response
TA-TMA is a serious complication of HSCT that can be life-threatening; the condition occurs from endothelial injury resulting in activation of the lectin pathway of complement; this leads to blood clot formation in small vessels which can result in organ (kidney, cardiovascular system, gastrointestinal tract) damage; TA-TMA has been predominantly managed with supportive care (e.g., modification of calcineurin inhibitor dosage, management of hypertension and acute kidney injury, treatment of infection)
Yartemlea is available from Omeros

None

Jan. 15, 2026 – filgrastim-laha (Filkri)

Biologics License Application (BLA) approval; 300 mcg/0.5 mL and 480 mcg/0.8 mL for SC or intravenous (IV) use in a single-dose prefilled syringe (PFS) received FDA approval as biosimilar to the same presentations of filgrastim (Neupogen)
Product will be available from Accord with launch timeframe to be determined (TBD)

Jan. 12, 2026 – imiglucerase (Cerezyme)

Genzyme; hydrolytic lysosomal glucocerebrosidase-specific enzyme
Expanded indication: additions to the indication to include treatment of Type 3 Gaucher disease in adult and pediatric patients and for expansion of the Type 1 Gaucher disease patient population to pediatric patients < 2 years of age; previously, only indicated for the treatment of adults and pediatric patients ≥ 2 years of age with Type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, hepatomegaly or splenomegaly; updated indication states for the treatment of non-CNS manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients
Administered by a health care professional (HCP) as a weight-based IV dose with administration ranging from three times a week to once every two weeks; dosage is titrated based on disease severity and therapeutic goals; requires initiation in a health care setting with appropriate monitoring and support for management of hypersensitivity reactions

Jan. 27, 2026 – daratumumab and hyaluronidase-fihj (Darzalex Faspro)

Janssen; combination of a CD38-directed cytolytic antibody (daratumumab) and an endoglycosidase (hyaluronidase); Assessment Aid
New indication: in combination with bortezomib, lenalidomide and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT); already approved for adults with newly diagnosed multiple myeloma in combination with VRd for induction and consolidation in patients who are eligible for ASCT
Administered as a SC injection into the abdomen over approximately three to five minutes by an HCP; administer according to the recommended three-week cycle schedule: weekly for a total of six doses, every three weeks for a total of six doses then every four weeks until disease progression
Other indications are detailed in the product label

Feb. 10, 2026 – pembrolizumab (Keytruda)

Merck; programmed death receptor-1 (PD-1)-blocking antibody; Assessment Aid, Priority Review, Project Orbis; the FDA also approved Agilent’s companion diagnostic device: PD-L1 IHC 22C3 pharmDx
New indication: in combination with paclitaxel, with or without bevacizumab, for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens
Administered as an IV infusion by an HCP every three weeks or every six weeks until disease progression, unacceptable toxicity or up to 24 months; administer prior to paclitaxel when given on the same day
Other indications are detailed in the product label

Feb. 10, 2026 – pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)

Merck; combination of a PD-1-blocking antibody (pembrolizumab) and an endoglycosidase (berahyaluronidase alfa); Assessment Aid, Priority Review, Project Orbis; the FDA also approved Agilent’s companion diagnostic device: PD-L1 IHC 22C3 pharmDx 
New indication: in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test and who have received one or two prior systemic treatment regimens
Administered as a SC injection by an HCP in the thigh or abdomen every three weeks or every six weeks until disease progression, unacceptable toxicity or up to 24 months; administer prior to paclitaxel when given on the same day
Other indications are detailed in the product label

Feb. 12, 2026 – aflibercept-abzv (Enzeevu)

Sandoz; vascular endothelial growth factor (VEGF) inhibitor; biosimilar to aflibercept (Eylea)
New indications: for the treatment of patients with macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR)
Administered as an intravitreal injection by a qualified physician; for macular edema following RVO administered once every four weeks (approximately every 25 days, monthly); recommended dosage for DME and DR is administered every four weeks (approximately every 28 days, monthly) for the first five injections followed by an injection once every eight weeks (two months)
Other indication: treatment of patients with neovascular (wet) age-related macular degeneration

Feb. 13, 2026 – pitolisant (Wakix)

Harmony; histamine-3 receptor antagonist/inverse agonist
New indication: for the treatment of cataplexy in patients ≥ 6 years of age with narcolepsy; previously indicated in pediatric patients only for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy and in adults with EDS or cataplexy with narcolepsy
Administered orally once daily in the morning upon wakening; requires weekly titration to the maximum dose that is dependent on patient body weight

Traditional

None

Jan. 26, 2026 – folic acid oral solution (Quiofic)

505(b)(2) NDA approval; other formulations of folic acid include the following: oral capsule, oral tablet, solution for injection and an OTC oral solution (PureVita)
Folate analog
Indicated for the treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients
Oral solution: 0.2 mg/mL
Recommended dosage is taken orally daily with or without food
Product will be available from Solubiomix with launch timeframe TBD

Jan. 28, 2026 – carbachol and brimonidine tartrate ophthalmic solution (Yuvezzi)

505(b)(2) NDA approval; approval marks the first combination eye drop approved to treat presbyopia
Combination of a cholinergic agonist (carbachol) and an alpha-adrenergic receptor agonist (brimonidine)
Indicated for the treatment of presbyopia in adults
Ophthalmic solution: carbachol 2.75% and brimonidine tartrate 0.1% in a single-dose vial
Recommended dosage is to instill one drop in each eye once daily
Product will be available from Tenpoint in the second quarter of 2026

Feb. 3, 2026 – leucovorin calcium injection (Vykoura)

505(b)(2) NDA approval
Folate analog
Indicated for (1) rescue after high-dose methotrexate therapy in adult and pediatric patients, (2) reducing the toxicity of methotrexate in adult and pediatric patients with impaired methotrexate elimination or folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients, (3) treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible and (4) treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil
Limitation of use: not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12, because of the risk of progression of neurologic manifestations despite hematologic remission
Solution for injection: 50 mg/5 mL, 350 mg/35 mL and 500 mg/50 mL (10 mg/mL) in a single-dose vial
Recommended dosage is administered IV or intramuscularly (IM) with dosage regimen dependent on indication
Product will be available from Avyxa with launch timeframe TBD

Jan. 16, 2026 – etonogestrel implant (Nexplanon)

Organon; progestin; approval includes a new REMS program to mitigate complications due to improper insertion and removal
Expanded indication: for prevention of pregnancy in women of reproductive potential for up to five years; previously, indicated for prevention of pregnancy in women for up to three years
Administered as one Nexplanon implant inserted subdermally under the skin at the inner side of the non-dominant upper arm; the implant requires removal by the end of the fifth year; all HCPs should receive instruction/training before performing insertion and/or removal of the implant

Jan. 23, 2026 – suzetrigine (Journavx)

Vertex; sodium channel blocker
Expanded indication: to include postoperative pain; updated indication states for the treatment of moderate to severe acute pain, including postoperative pain, in adults; previously, indication stated for the treatment of moderate to severe acute pain in adults
Administered orally as a loading dose taken on an empty stomach at least one hour before or two hours after food; beginning 12 hours after the starting dose, take the maintenance dose orally every 12 hours with or without food; use for the shortest duration; use for the treatment of acute pain has not been evaluated beyond 14 days

Jan. 27, 2026 – posaconazole (Noxafil)

Merck Sharp & Dohme; azole antifungal
Expanded indication: for treatment of invasive aspergillosis to include patients 2 years of age to < 13 years of age who weigh ≥ 10 kg for Noxafil injection and patients 2 years of age to < 13 years of age who weigh ≥ 40 kg for Noxafil delayed-release tablets; additionally, the indication for treatment of invasive aspergillosis in patients ≥ 2 years of age who weigh 10 kg to 40 kg was approved for Noxafil PowderMix for delayed-release oral suspension; previously, only the injection and delayed-release tablets were indicated for the treatment of invasive aspergillosis in adults and pediatric patients ≥ 13 years of age
Administered twice daily on the first day, followed by maintenance dose once a day starting on the second day; the Noxafil injection dosage is weight based (mg/kg); the dosage for Noxafil PowderMix is based on body weight and is not recommended for use in pediatric patients > 40 kg as the recommended dosage cannot be achieved with this dosage form; treatment for invasive aspergillosis is for a total duration of six to 12 weeks
Other indications are detailed in the product label

Feb. 12, 2026 – inclisiran (Leqvio)

Novartis; small interfering RNA (siRNA) directed to proprotein convertase subtilisin kexin type 9 (PCSK9) mRNA
Expanded indication: to include pediatric patients ≥ 12 years of age with heterozygous familial hypercholesterolemia (HeFH); previously indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH
New indication: an adjunct to diet and exercise to reduce LDL-C in pediatric patients ≥ 12 years of age with homozygous familial hypercholesterolemia (HoFH)
Administered by an HCP SC given initially, again at three months and then every six months

First generic drug launches

Dec. 18, 2025 – loteprednol etabonate and tobramycin (Zylet)

Alembic launched a generic ophthalmic suspension (0.5%/0.3%) to Bausch’s Zylet
Combination of a corticosteroid (loteprednol etabonate) and an aminoglycoside (tobramycin); indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists
Recommended dosage is to apply one or two drops of ophthalmic suspension into the conjunctival sac of the affected eye every four to six hours
Annual sales for Zylet in 2025 was < $10 million

Jan. 9, 2026 – sodium oxybate (Xyrem)

Ascent launched a generic oral solution (0.5 g/mL) to Jazz’s Xyrem
CNS depressant; indicated for the treatment of cataplexy or EDS in patients ≥ 7 years of age with narcolepsy 
Recommended dosage in adults is taken orally at night in two divided doses with titration to effect at weekly intervals; for pediatric patients, the starting dosage, titration regimen and maximum nightly total dosage are based on body weight
Annual sales for Xyrem in 2025 are TBD

Jan. 14, 2026 – olopatadine hydrochloride (Pataday Once Daily Relief)

Gland launched generic ophthalmic OTC solution (0.7%) to Alcon’s Pataday Once Daily Relief
Antihistamine; for temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander
Recommended dosage is one drop in the affected eye(s) once daily
Annual sales for Pataday Once Daily Relief in 2025 was $22 million

ASHP American Society of Health-System Pharmacists

CD cluster of differentiation

CMS Centers for Medicare & Medicaid Services

CNS central nervous system

FDA Food and Drug Administration

LDL-C low-density lipoprotein cholesterol

MACE major adverse cardiovascular events

mRNA messenger ribonucleic acid

OTC over the counter

PD-L1 programmed-death ligand 1

REMS Risk Evaluation and Mitigation Strategy

Rx prescription

U.S. United States

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 health care provider.
All brand names are property of their respective owners.

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