FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.

F.D.A. Sharply Limits Use of Drug Linked to Two Teen Deaths

A gene therapy for Duchenne muscular dystrophy caused complications to the liver, prompting a review of its use for younger patients.
MPR

FDA Approves Poherdy, the First Interchangeable Biosimilar to Perjeta

Poherdy can be dispensed as a substitute for Perjeta without requiring a prescription change from a health care provider.
Becker's Hospital Review

FDA approves 1st biosimilar to breast cancer drug Perjeta

FDA approves 1st biosimilar to Perjeta, Poherdy, for HER2-positive breast cancer treatment, enabling pharmacy-level substitution under state law.
Healio

FDA taps ‘visionary’ oncology leader to serve as top drug regulator

The FDA on Nov. 11 appointed Richard Pazdur, MD, as the new director of the Center for Drug Evaluation and Research.Pazdur joined the FDA in 1999 and recently served as founding director of the ...