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On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or …

FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer Read More »

FDA has approved Hovilpri (pritelivir) tablets for adults with weakened immune systems (i.e., immunocompromised patients) who have mucocutaneous lesions caused by herpes simplex virus (HSV) infection and have not responded to other therapies (acyclovir, valacyclovir, or famciclovir). Mucocutaneous lesions occur on skin or mucosal surfaces, such as lips, nostrils, eyes and genitals.

The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027. The initiative contributes to higher-quality applications and more efficient clinical trial assessment processes, by strengthening cooperation across the European medicines regulatory network.

The FDA issued a final guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers. This guidance provides biological product manufacturers with recommendations on the nature and type of information they should provide FDA to support postapproval manufacturing changes to licensed (approved) biosimilar and interchangeable biosimilar products.

On October 7, 2026, the Food and Drug Administration approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.