RxNews®

April 22, 2026 - Sanofi and Regeneron announced the FDA approval of Dupixent (dupilumab), for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

April 27, 2026 - AstraZeneca announced the FDA approval of Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate), for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.

April 21, 2026 - Merck announced the FDA approval of Idvynso (doravirine/islatravir), for the treatment of HIV-1 infection in adults to replace current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

April 23, 2026 - Regeneron announced the FDA approval of Otarmeni (lunsotogene parvec-cwha), for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency > 90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear.

April 27, 2026 - AstraZeneca announced the FDA approval of subcutaneous (SC) Saphnelo (anifrolumab-fnia), for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.

April 22, 2026 - Pfizer announced a business decision to discontinue Ibrance (palbociclib) capsules. Ibrance is not being discontinued for reasons of safety or effectiveness.

April 27, 2026 - The FDA proposed that Tavneos (avacopan) be withdrawn from the market because new information indicates that Tavneos has not been shown to be effective for its approved use, and because the application that resulted in FDA approval contained untrue statements of material fact.