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 …
U.S. Food and Drug Administration (FDAU.S. Food and Drug Administration (FDA) approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).) approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication …
FDA approves epcoritamab-bysp for follicular lymphoma indications Read More »
