Regulatory
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.
The FDA raised doubts about the future of Ardelyx’s experimental chronic kidney disease drug tenapanor in briefing documents released ahead of a Wednesday advisory committee meeting.
During its third-quarter earnings call Monday, BrainStorm Cell Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in ALS.
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
A gene therapy being developed by Eikonoklastes Therapeutics to treat ALS received Orphan Drug Designation, the company announced Wednesday.
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