Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression
On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
The European Commission has launched a call for expressions of interest to represent patient and healthcare professional organisations in EMA’s Paediatric Committee (PDCO). Three members and alternates from patient organisations and three members and alternates from healthcare professional organisations will be appointed for a three-year mandate starting on 1 August 2026.
EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and in children from 8 years of age with stage 2 type 1 diabetes.
U.S. Food and Drug Administration approved VKT Pharma’s reformulated Ranitidine tablets in 150 mg and 300 mg strengths, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s …
On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats. Under the new process, developers of medicines falling within the scope of the ETF’s activities, including medicines for antimicrobial resistance (AMR) and other health threats that have the potential to cause public health emergencies, …
EMA has recommended granting a marketing authorisation in the European Union (EU) for Waskyra (etuvetidigene autotemcel) to treat people aged 6 months and older with Wiskott-Aldrich syndrome (WAS) who have a mutation in the WAS gene. Waskyra is used to treat patients for whom a haematopoietic stem cell transplantation (HSCT) is appropriate, but for whom no suitable …
EMA: First gene therapy to treat rare disease Wiskott-Aldrich syndrome Read More »
On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
On November 17, 2025, the FDA published the final guidance for industry, “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use,” which helps applicants prepare an abbreviated new drug application (ANDA) that references a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but …
