Regulatory
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
Spectrum Pharmaceuticals made the call Friday to slash three-fourths of its workforce on the heels of a Complete Response Letter from the FDA.
The FDA has accepted Sarepta’s BLA for the accelerated approval of SRP-9001, an investigational gene therapy for DMD. Roche is responsible for commercialization outside the U.S.
BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
The FDA granted argenx Priority Review status for the company’s BLA for SC efgartigimod for generalized myasthenia gravis.
Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.
The FDA has a number of PDUFA dates for the remainder of November for Spectrum, ImmunoGen, Scynexis and Y-mAbs.
Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.
The FDA has requested that Clovis Oncology limit the indication of its PARP inhibitor Rubraca as second-line maintenance therapy in recurrent ovarian cancer.
Ardelyx has moved one step closer to the possible approval of its experimental chronic kidney disease drug tenapanor following a favorable 9-4 vote from an FDA advisory committee.
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