Regulatory
Vertex Pharmaceuticals is marching toward the launch of exa-cel with a lot of confidence, per its full-year 2022 presentation.
The FDA’s Oncologic Drugs Advisory Committee voted 8-5 that two single-arm trials would be “sufficient to characterize the benefits and risks” of Jemperli in locally advanced rectal cancer.
GSK has dropped two assets, an investigational celiac disease therapeutic and a Staphylococcus aureus vaccine hopeful, from its pipeline.
The FDA asked Taysha Gene Therapies to dose more patients in a double-blinded, placebo-controlled trial before submitting a BLA for its giant axonal neuropathy candidate.
Novartis’ SCD therapeutic Adakveo is under review by the EMA after failing to replicate previous efficacy results in a Phase III trial.
The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.
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