publications

The National Center for Health Statistics (NCHS) has released two new reports on the prevalence of overweight, obesity and severe obesity in adults (≥ 20 years of age) and children/adolescents (2 to 19 years of age) in the U.S. Between August 2021 and August 2023, 40.3% of adults ≥ 20 years of age had obesity, 9.7% had severe obesity and 31.7% were considered overweight. During the same period, 21.1% of children and adolescents had obesity with 7% having severe obesity, and an additional 15.1% were considered overweight.

The Food and Drug Administration (FDA) has approved a medical device called the Allurion Gastric Balloon System (AGBS), including the Allurion Smart Capsule, indicated to promote short-term limited weight loss in adults 22 to 65 years of age with obesity (body mass index [BMI] ≥ 30 kg/m² and ≤ 40 kg/m²) who have had at least one unsuccessful attempt at a weight loss program. The Smart Capsule, which contains a swallowable gastric balloon attached to a thin tube, can be administered during a 15 minute outpatient visit. Once swallowed, the balloon is filled with liquid by a health care professional (HCP) promoting a feeling of fullness. The system is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The balloon automatically opens and drains through a release valve after about four months and passes out of the body. A second balloon can be placed about 24 weeks after the initial balloon placement or about two months following passage of the first, whichever occurs first. This allows for up to two Allurion Balloons to be used during a 10-month period.

The FDA issued 30 warning letters to telehealth companies for making false or misleading claims about compounded glucagon-like peptide-1 (GLP-1) receptor agonists on their websites. The Agency has sent thousands of letters since the September 2025 initiative began to address misleading direct-to-consumer pharmaceutical advertisements. Violations include making improper claims that imply sameness to FDA-approved products and concealing the source of the products by branding them with the telehealth firm’s name or trademark, suggesting that the company is the compounder. Hims & Hers Health, Inc. previously received warning letters in September 2025 due to unlawful sale of unapproved and misbranded drugs to U.S. consumers. However, in early March 2026, they announced a collaboration with Novo Nordisk to provide GLP-1 users with access to FDA-approved injectable and oral therapies with compounded semaglutide offered through the platform on a limited scale. Additionally, compounded GLP-1s will not be advertised and current patients will be given the opportunity to transition to FDA-approved therapies if determined appropriate by their HCP; access to compounded GLP-1s is expected only for a limited number of patients whose needs cannot be met by FDA-approved products.

The Agency has launched the new Adverse Event Monitoring System (AEMS), a unified platform for analyzing adverse event (AE) reports. AE reports submitted to the FDA for drugs, biologics, vaccines, cosmetics and animal food will be displayed in a single streamlined dashboard. In the coming months, the remaining product centers will start processing AE reports in AEMS and historical data will be migrated to the new system. Legacy drug and vaccine reporting systems that will be replaced by AEMS include FDA Adverse Event Reporting System (FAERS) and Vaccine Adverse Event Reporting System (VAERS). By the end of May 2026, AEMS will provide real-time reporting of AEs for all FDA-regulated products.
The FDA hosted a forum with several states to discuss the section 804 importation program (SIP), which is designed to allow states and Indian tribes to import certain prescription drugs from Canada. The intent of the importation program is to decrease prescription drug costs. The FDA has also offered states/tribes the opportunity to submit draft SIP proposals for pre-review and to meet with the Agency for feedback before submitting the finalized proposals. The Agency launched the SIP quality assurance tool in January 2026 to assist sponsors in preparation of proposals that are in full compliance with the final rule requirements.

The Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report (MMWR) on respiratory virus activity in the U.S. from July 1, 2024 to June 30, 2025. Severe outcomes were observed from coronavirus disease 2019 (COVID-19) and respiratory syncytial virus (RSV), particularly in young children and older adults. An estimated 290,000 to 450,000 hospitalizations and 34,000 to 53,000 deaths were associated with COVID-19 during this time frame, and RSV was associated with 190,000 to 350,000 hospitalizations and 10,000 to 23,000 deaths.
The CDC published an MMWR on antiviral prescription receipt among outpatients ≥ 65 years of age from June 1, 2023 to Sept. 30, 2025. During periods of low COVID-19 incidence, 16% to 23% of outpatients aged ≥ 65 years old with COVID-19 received an antiviral prescription compared with 37% to 38% during higher incidence periods. Patients 75 to 84 years of age and ≥ 85 years of age were more likely to receive an antiviral prescription than were those aged 65 to 74 years.
As of March 20, 2026, the CDC announced that the amount of acute respiratory illness resulting in people seeking health care is low. Influenza activity remains elevated across the country but is decreasing in most parts of the U.S. RSV activity is elevated but has peaked in many regions. COVID-19 activity is decreasing in most parts of the U.S. The CDC reports influenza-like illness (ILI) for the week ending March 14, 2026 (week 10); influenza A(H3N2) and influenza B are the most frequently reported influenza viruses. ASHP is reporting shortages of the antiviral oseltamivir (Tamiflu).
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened March 12, 2026. The advisory committee voted for the upcoming 2026–2027 influenza vaccines to have a trivalent composition comprised of two influenza A viruses (H1N1 and H3N2) and one influenza B virus (Victoria lineage) strain. The recommended egg-based influenza virus vaccine strains are A/Missouri/11/2025 (H1N1)pdm09-like virus, A/Darwin/1454/2025 (H3N2)-like virus and B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus. The recommended cell culture-, recombinant protein- and nucleic acid-based vaccines are A/Missouri/11/2025 (H1N1)pdm09-like virus, A/Darwin/1415/2025 (H3N2)-like virus and  B/Pennsylvania/14/2025 (B/Victoria lineage)-like virus.
The Pan American Health Organization (PAHO) has announced the measles elimination status in the U.S. will be reviewed in November 2026, during the Commission’s regular annual meeting of the Regional Verification Commission for the Elimination of Measles, Rubella and Congenital Rubella Syndrome (RVC). Previously, the U.S. measles elimination status was planned for review virtually on April 13, 2026, but this has been postponed to November.
The CDC reports, as of March 19, 2026, that there have been 1,487 confirmed cases of measles in the U.S. in 2026. Cases include, 21% in individuals < 5 years of age, 53% in those 5 to 19 years of age, 26% in those ≥ 20 years of age and 1% with unknown age; 92% 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 March 20, 2026, IVAC reported 1,567 total cases in the U.S. in 2026.

The 2026 statistics for colorectal cancer (CRC) have been published by the American Cancer Society. In adults < 50 years of age, CRC is the most common cancer-related death in the U.S. Overall, CRC is the second most common cancer-related death in the country.
The American Heart Association (AHA) has published a scientific statement forecasting the burden of cardiovascular (CV) disease and stroke in women in the U.S. through 2050. Coronary disease, heart failure, stroke, atrial fibrillation and total CV disease and stroke are expected to increase.
The American Society of Hematology (ASH) has published evidence-based guidelines for frontline management of acute lymphoblastic leukemia (ALL) in adolescents and young adults. Fifteen recommendations as well as several practice statements are provided.
The Institute for Clinical and Economic Review (ICER) has published a special report on vedolizumab (Entyvio) for the treatment of ulcerative colitis and Crohn's disease. The report will be submitted to CMS as part of the 2026 public comment process for Medicare Drug Price Negotiations for year 2028.

Drug Approvals

Specialty

Feb. 23, 2026 – pegzilarginase-nbln (Loargys)

Biologics License Application (BLA) approval; Accelerated Approval, Orphan Drug
Arginine specific enzyme
Indicated for the treatment of hyperargininemia in adult and pediatric patients ≥ 2 years of age with arginase 1 deficiency (ARG1-D), in conjunction with dietary protein restriction; Accelerated Approval is based on reduction of plasma arginine and continued approval for this use may require demonstration of benefit in confirmatory clinical trials
Solution for injection: 2 mg/0.4 mL and 5 mg/mL in a single-dose vial
Recommended starting dosage is weight-based administered as an intravenous (IV) infusion once weekly and requires initiation in a health care setting with appropriate monitoring and measures (e.g., cardiopulmonary resuscitation equipment); administration should only occur under the supervision of a health care professional (HCP) knowledgeable in managing hypersensitivity reactions, including anaphylaxis; premedication with antihistamines should be considered; following eight weeks of once weekly IV doses, patients can be switched to once weekly subcutaneous (SC) dosing at the same dose as administered IV; if maintenance SC administration is tolerated, patients may receive SC administration at home under the supervision of an HCP; product labeling provides details on titration and maintenance dosing as well as recommended plasma arginine level testing during therapy
Approval was based on a randomized, double-blind, placebo-controlled, parallel-group, multinational, phase 3 clinical trial (PEACE; n=32); the primary endpoint of change from baseline in plasma arginine (PArg) after 24 weeks was significantly improved with pegzilarginase compared to placebo as demonstrated by a significantly greater reduction in the geometric mean PArg level (pegzilarginase [baseline to week 24]: 354 μmol/L to 86.4 μmol/L versus placebo: 464.7 μmol/L to 426.6 μmol/L; 95% confidence interval [CI], -67.1% to -83.5%; p<0.0001); furthermore, at week 24, 90.5% of patients experienced normalized PArg levels compared with no placebo patients experiencing normalized levels
ARG1-D is an ultra-rare (250 patients in the U.S.) autosomal recessive genetic urea cycle disorder caused by a deficiency in the arginase enzyme; this deficiency results in accumulation of nitrogen (in the form of ammonia and arginine); in ARG1-D, arginine accumulation is the primary abnormality (not excess ammonia); although most infants with ARG1-D can now be identified at birth through newborn screening, without treatment these children experience progressive spasticity, seizures, developmental delay/intellectual disability and early death; treatment modalities include sodium phenylacetate/sodium benzoate (Ammonul), sodium phenylbutyrate (Buphenyl) or glycerol phenylbutyrate (Ravicti) (to remove excess nitrogen); dialysis (to reduce plasma ammonia levels); dietary restriction (to limit arginine and protein intake); and symptomatic management (seizures treated with anticonvulsants); Loargys is the first FDA-approved therapy to specifically address the elevated plasma arginine levels occurring in patients with ARG1-D
Boxed warning for hypersensitivity reactions including anaphylaxis
Loargys is available from Immedica

Feb. 27, 2026 – navepegritide (Yuviwel)

New Drug Application (NDA) approval; Accelerated Approval, Orphan Drug, Priority Review, Rare Pediatric Disease Priority Review voucher
C-type natriuretic peptide (CNP) analog
Indicated to increase linear growth in pediatric patients ≥ 2 years of age with achondroplasia with open epiphyses; Accelerated Approval is based on improvement in annualized growth velocity and continued approval for this use may require demonstration of benefit in confirmatory clinical trials
Lyophilized powder for reconstitution: 1.3 mg, 2.8 mg and 5.5 mg in single-dose vials
Recommended dosage is based on body weight and is administered once weekly by SC injection; growth should be monitored periodically with dose adjustments according to body weight; discontinue when there is no further growth potential as indicated by epiphyseal closure; patients/caregivers should receive training by an HCP prior to administration
Approval was based on data from a randomized, double-blind, placebo-controlled, phase 2b study (ApproaCH; n=84) that evaluated treatment-naïve pediatric patients 2 to 11 years of age with genetically confirmed achondroplasia; based on the primary endpoint of annualized growth velocity at 52 weeks, navepegritide was superior to placebo (least-squares mean treatment difference of 1.49 cm/year; 95% CI, 1.05 to 1.93; p<0.001)
Vosoritide (Voxzogo) is also a CNP analog that received Accelerated Approval to increase linear growth in pediatric patients with achondroplasia with open epiphyses; this Accelerated Approval was also based on an improvement in annualized growth velocity; Voxzogo is administered SC once daily
Yuviwel is available from Ascendis

None

Feb. 23, 2026 – dupilumab (Dupixent)

Regeneron; interleukin-4 receptor alpha antagonist; first approval for allergic fungal rhinosinusitis (AFRS); Priority Review
New indication: the treatment of adult and pediatric patients ≥ 6 years of age with AFRS who have a history of sino-nasal surgery
Administered SC as a fixed dose every two weeks in adults; for pediatric patients 6 to 17 years of age, dosing is based on body weight and is given every two weeks for patients with body weight ≥ 30 kg and every four weeks for patients with a body weight of 15 kg to < 30 kg; patients/caregivers can administer following proper training
Other indications are detailed in the product label

Feb. 25, 2026 – lomitapide (Juxtapid)

Chiesi; microsomal triglyceride transfer protein inhibitor; the FDA also approved a new 2 mg strength capsule for the expanded pediatric population
Expanded indication: the current homozygous familial hypercholesterolemia (HoFH) indication has been expanded to include pediatric patients ≥ 2 years of age; previously, Juxtapid was only indicated for use in adults; the updated indication is as an adjunct to a low-fat diet and exercise and other LDL-C therapies, to reduce LDL-C in adult and pediatric patients ≥ 2 years of age with HoFH
Administered orally once daily with a glass of water, without food, at least two hours after the evening meal; initiation dosage is 2 mg for patients 2 to 15 years of age and 5 mg for patients ≥ 16 years of age; this is followed by a titration schedule according to the patient’s age with the dosage based on recommended target LDL-C, safety and tolerability

Feb. 26, 2026 – zongertinib (Hernexeos)

Boehringer Ingelheim; kinase inhibitor; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Commissioner's National Priority Voucher (CNPV), Priority Review, Real-Time Oncology Review (RTOR)
Expanded indication: for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test; Accelerated Approval is based on objective response rate and duration of response; therefore, continued approval for this use may require demonstration of benefit in confirmatory clinical trials; this indication was previously limited to patients who had received prior systemic therapy
Administered orally once daily with or without food until disease progression or unacceptable toxicity; recommended dosage is based on body weight (< 90 kg and ≥ 90 kg)

Feb. 27, 2026 – pegvaliase-pqpz (Palynziq)

BioMarin;  phenylalanine (Phe)-metabolizing enzyme
Expanded indication: to include pediatric patients with phenylketonuria (PKU) ages 12 to < 18 years of age; previously, only indicated for adults; updated indication is to reduce blood Phe concentrations in adult and pediatric patients ≥ 12 years of age with PKU who have uncontrolled blood Phe concentrations > 600 μmol/L on existing management
Administered as an initial SC dose once weekly for four weeks; the dose is then titrated in a step-wise manner, based on tolerability, over at least five weeks; the maintenance dose should be the lowest effective and tolerated dose individualized to achieve blood Phe control; initial administration and/or readministrations after an anaphylaxis episode should be performed under the supervision of an HCP equipped for managing anaphylaxis with close observation for a minimum of 60 minutes after the injection; patients should be confirmed to have competency with self-administration using aseptic technique before self-administration

Feb. 27, 2026 – somapacitan-beco (Sogroya)

Novo Nordisk; human growth hormone analog
New indications: for treatment of pediatric patients ≥ 2.5 years of age with (1) short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age, (2) growth failure associated with Noonan syndrome (NS) and (3) idiopathic short stature (ISS); existing pediatric indication is for the treatment of pediatric patients ≥ 2.5 years of age with growth failure due to inadequate secretion of endogenous growth hormone
Administered as a weight-based dose by SC injection once weekly at any time of the day, administered by a patient/caregiver following proper training; dosage should be individualized based on growth response; administered in the upper arms, thigh, abdomen or buttocks with regular rotation of injection site to avoid lipohypertrophy/lipoatrophy
Other indication: as replacement of endogenous growth hormone in adults with growth hormone deficiency

March 5, 2026 – teclistamab (Tecvayli)

Janssen Biotech; bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager; Breakthrough Therapy, CNPV, RTOR; FDA also converted the Accelerated Approval to traditional approval for Tecvayli monotherapy for adults with relapsed or refractory multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
New indication: in combination with daratumumab/hyaluronidase-fihj (Darzalex Faspro), also known as Tec-Dara, for the treatment of adults with relapsed or refractory MM who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
Administered SC according to step-up dosing schedules to decrease the incidence and severity of cytokine release syndrome (CRS); due to the risk of CRS and neurologic toxicity, patients require hospitalization for 48 hours after administration of both step-up doses one and two; patients should also remain within proximity to a health care facility and be monitored daily for 48 hours after the first treatment dose within the step-up dosing schedule; specific dosing schedule details are provided in the product labeling; administer until disease progression or unacceptable toxicity

March 6, 2026 – deucravacitinib (Sotyktu)

Bristol Myers Squibb; tyrosine kinase 2 (TYK2) inhibitor; first TYK2 inhibitor to be approved for psoriatic arthritis (PsA)
New indication: treatment of active PsA in adults
Administered orally once daily, with or without food
Other indication: treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy (not recommended for use in combination with other potent immunosuppressants)

Traditional

Feb. 12, 2026 – difamilast (Adquey)

505(b) NDA approval
Phosphodiesterase 4 (PDE4) inhibitor
Indicated for the topical treatment of adults and pediatric patients ≥ 2 years of age with mild to moderate atopic dermatitis
Topical ointment: 1%
Recommended dosage is applied topically as a thin layer twice daily to affected areas and rubbed in completely
Approval was based on data from three multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (n=612); trial 1 enrolled patients ≥ 10 years of age in the U.S., Australia and Poland and trials 2 and 3 were conducted in Japan and enrolled patients ≥ 15 years of age and 2 to 14 years of age, respectively; the primary efficacy endpoint for all trials was the proportion of subjects who achieved Investigator's Global Assessment (IGA) success, defined as an IGA grade of clear (0) or almost clear (1) and with a 2-grade or greater improvement from baseline, at week 4; a significantly greater proportion of patients in all three studies achieved IGA success (difference from vehicle: trial 1, 18%; 95% CI, 5 to 31; trial 2, 26%; 95% CI, 17 to 34; trial 3, 29%; 95% CI, 15 to 42)
Roflumilast (Zoryve) is also a PDE4 inhibitor indicated for the topical treatment of mild to moderate atopic dermatitis; it is supplied as a cream (0.05%, 0.15%, 0.3%); the 0.05% strength is applied once daily and indicated for use in pediatric patients 2 to 5 years of age and the 0.15% strength is applied once daily and is indicated for use in pediatric patients ≥ 6 years of age and adults; crisaborole (Eucrisa) is a PDE4 inhibitor supplied as a topical ointment that is also applied twice daily; it is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients ≥ 3 months of age
Adquey will be available from Acrotech with launch timeframe to be determined (TBD)

Feb. 20, 2026 – milsaperidone (Bysanti)

NDA approval
Atypical antipsychotic
Indicated for (1) treatment of schizophrenia in adults and (2) acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
Oral tablets: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg
Recommended dosage is taken orally twice daily with or without food; titrate to decrease the risk of orthostatic hypotension
Approval was based on data from iloperidone which rapidly interconverts in vivo to milsaperidone; adequate and well controlled studies of iloperidone tablets in adults with schizophrenia and adults with manic or mixed episodes associated with bipolar I disorder were used to demonstrate effectiveness
Iloperidone (Fanapt) is also an atypical antipsychotic FDA-approved for the same uses as Bysanti; it is taken orally twice daily without regard to meals and also requires titration to avoid orthostatic hypotension; Bysanti has demonstrated bioequivalence to iloperidone and provides dual active molecules (iloperidone and milsaperidone) due to rapid interconversion resulting in antagonism of dopamine type 2 (D2) and serotonin type 2 (5-HT2) receptors
Boxed warning for increased mortality in elderly patients with dementia-related psychosis
Bysanti will be available from Vanda with launch expected in the third quarter of 2026

Feb. 25, 2026 – desmopressin (Desmoda)

505(b)(2) NDA approval; the first FDA-approved desmopressin oral solution
Vasopressin analog
Indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients
Limitations of use: not indicated for the treatment of nephrogenic diabetes insipidus
Oral solution: 0.05 mg desmopressin acetate in 1 mL (0.05 mg/mL)
Recommended starting dosage is taken orally twice daily; daily dosage should then be titrated as needed to achieve adequate antidiuretic response; dose should be administered using an oral syringe and on an empty stomach, at least one hour prior to or two hours after food; monitor response based on urine volume and osmolarity; plasma osmolarity can also be used; dosage should be individualized according to diurnal patterns of response (patient response can be estimated based on duration of sleep and water turnover); patients should be counseled on appropriate fluid restriction due to the risk for hyponatremia
Product is available from Eton

Feb. 27, 2026 – darunavir and cobicistat tablets for oral suspension (Prezcobix Ped)

NDA approval; the combination of darunavir and cobicistat (Prezcobix) is also available as an oral tablet in the strengths of 800 mg/150 mg and 675 mg/150 mg
Two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a cytochrome P450 (CYP) 3A inhibitor
Indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced pediatric patients ≥ 3 years of age and weighing ≥ 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V)
Tablet for oral suspension: 600 mg of darunavir/90 mg of cobicistat
Recommended dosage in pediatric patients ≥ 3 years of age weighing ≥ 15 kg to < 25 kg is one 600 mg/90 mg tablet for oral suspension taken once daily with food; Prezcobix Ped tablet requires dispersion in drinking water and then should be taken immediately with food
Product will be available from Janssen with launch timeframe TBD

Feb. 26, 2026 – rizatriptan (RizaFilm)

Gensco; serotonin (5-HT) 1B/1D receptor agonist (triptan); FDA also approved a new 5 mg strength of the oral film

Expanded indication: for acute treatment of migraine with or without aura to include pediatric patients 6 to 11 years of age; previously, indicated only for the acute treatment of migraine with or without aura in adults and pediatric patients 12 to 17 years of age weighing ≥ 40 kg
Limitations of use: not indicated for the preventive treatment of migraine or for treatment of cluster headache; use only after a clear diagnosis of migraine has been established
Administered for pediatric patients 6 to 17 years of age as a 5 mg single dose for patients < 40 kg and a 10 mg single dose in pediatric patients ≥ 40 kg

March 9, 2026 – leucovorin calcium (Wellcovorin)

GlaxoSmithKline; folate analog
New indication: for the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD)
Limitations of use: not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate
Administered orally based on body weight (< 40 kg or ≥ 40 kg) dosed in mg/kg/day; the total daily dosage can be administered once daily or in divided doses up to six times per day; single doses of ≤ 25 mg are preferred (do not administer > 75 mg as a single dose)
Other indication: to reduce the toxicity of methotrexate in adults with impaired methotrexate elimination and folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients

March 13, 2026 – respiratory syncytial virus (RSV) vaccine, adjuvanted (Arexvy)

GlaxoSmithKline; RSV vaccine for active immunization
Expanded indication: for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 18 to 49 years at increased risk for LRTD caused by RSV; previously approved for adults aged 50 to 59 years at increased risk for LRTD caused by RSV
Limitations of use: not for use in pregnant individuals
Administered as a single 0.5 mL intramuscular (IM) dose by an HCP
Other indication: prevention of RSV-related LRTD in adults ≥ 60 years of age

First generic drug launches

Feb. 10, 2026 – rilpivirine (Edurant)

Somerset launched a generic oral tablet (25 mg) to Janssen’s Edurant
HIV-1 specific non-nucleoside reverse transcriptase inhibitor (NNRTI); indicated (1) in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients ≥ 12 years of age and weighing ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL and (2) in combination with cabotegravir (Vocabria) for short-term treatment of HIV-1 infection in adults and adolescents ≥ 12 years of age and weighing ≥ 35 kg who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine
Recommended dosage is one tablet taken once daily with a meal for patients weighing ≥ 35 kg
Annual sales for Edurant in 2025 were $49 million

Feb. 21, 2026 – brivaracetam oral tablet (Briviact)

MSN Laboratories/Novadoz launched generic oral tablets (10 mg, 25 mg, 50 mg, 75 mg, 100 mg) to UCB’s Briviact; schedule V controlled substance
Anticonvulsant; indicated for the treatment of partial-onset seizures in patients ≥ 1 month of age
Recommended dosage is based on body weight and is administered orally twice daily in pediatric patients 1 month to < 16 years of age; for patients ≥ 16 years of age, the starting dosage for monotherapy or adjunctive therapy is taken twice daily and is adjusted based on individual patient tolerability and therapeutic response
Annual sales for Briviact oral tablet in 2025 are $878 million

Feb. 23, 2026 – brivaracetam oral solution (Briviact)

Alkem/Ascend launched generic oral solution (10 mg/mL) to UCB’s Briviact; schedule V controlled substance
Anticonvulsant; indicated for the treatment of partial-onset seizures in patients ≥ 1 month of age
Recommended dosage is based on body weight and is administered orally twice daily in pediatric patients 1 month to < 16 years of age; for patients ≥ 16 years of age, the starting dosage for monotherapy or adjunctive therapy is taken twice daily and is adjusted based on individual patient tolerability and therapeutic response
Annual sales for Briviact oral solution in 2025 are TBD

Feb. 28, 2026 – pomalidomide (Pomalyst)

Breckenridge launched generic oral capsules (1 mg, 2 mg, 3 mg, 4 mg) to Bristol Myers Squibb’s Pomalyst
Thalidomide analogue; indicated for the treatment of adults (1) in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy and (2) with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative (Accelerated Approval)
Recommended dosage is dependent on indication and is taken orally on days one through 21 of repeated 28-day cycles until disease progression for MM and until disease progression or unacceptable toxicity for KS
Annual sales for Pomalyst in 2025 were $3,299 million

AIDS acquired immunodeficiency syndrome

ASHP American Society of Health-System Pharmacists

CD cluster of differentiation

CDC Centers for Disease Control and Prevention

CMS Centers for Medicare & Medicaid Services

COVID-19 coronavirus disease 2019
ERBB2 Erb-B2 Receptor Tyrosine Kinase 2

FDA Food and Drug Administration

HER2 human epidermal growth factor receptor 2

LDL-C low-density lipoprotein cholesterol

RNA ribonucleic acid

RSV espiratory syncytial virus

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.
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