The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The FDA topped off last week with two approvals under its popular Real-Time Oncology Review (RTOR) program, granting new indications to AstraZeneca PLC/Daiichi Sankyo Co., Ltd.’s Enhertu in HER2-low breast cancer and Bayer AG/Orion Corporation’s Nubeqa in hormone-sensitive prostate cancer.
While both approvals came in advance of the user fee goal date, the two-month review of the new Enhertu indication...
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
