RxNews®

September 19, 2025 - COVID-19, MMRV, and Hepatitis B vaccines ACIP recommendations. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously voted to update the pediatric and adult immunization schedules for administration of FDA-approved COVID-19 vaccines as follows adults 65 and older: Vaccination based on individual-based decision-making* individuals 6 months to 64 years: Vaccination based on individual-based decision-making – with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors. Also known as shared clinical decision making

September 18, 2025 -  Incyte announced the FDA approval of Opzelura (ruxolitinib), for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

September 19, 2025 - J&J announced the FDA approval of a Tremfya (guselkumab), subcutaneous (SC) induction regimen for the treatment of adults with moderately to severely active ulcerative colitis (UC). 

September 15, 2025 - Krystal Biotech announced the FDA approval of Vyjuvek (beremagene geperpavec-svdt), for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

September 17, 2025 - Biocon Biologics announced the FDA approval of Aukelso (denosumab-kyqq), biosimilar to Amgen’s Xgeva® (denosumab). 

September 17, 2025 -  Biocon Biologics announced the FDA approval of Bosaya (denosumab-kyqq), biosimilar to Amgen’s Prolia® (denosumab).

September 19, 2025 - Stealth BioTherapeutics announced the FDA approval of Forzinity (elamipretide), to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. 

September 19, 2025 - Merck announced the FDA approval of Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph), in adults across most solid tumor indications for Keytruda® (pembrolizumab).

September 16, 2025 - Subvenite new drug approval. The FDA approved OWP Pharmaceuticals’ Subvenite (lamotrigine) oral suspension for Adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures; primary generalized tonic-clonic seizures; generalized seizures of Lennox-Gastaut syndrome; Conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug; Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

September 16, 2025 - Dr. Reddy’s Laboratories announced a voluntary withdrawal of two lots of ropinirole extended-release 2 mg tablets because of an Out of Trend result observed during the 18-month stability review of related substance data.