Approvals
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
Lexicon Pharmaceuticals’ LX9211 fell short of its primary efficacy endpoint, according to topline data from the Phase II RELIEF-PHN-1 study in post-herpetic neuralgia.
The FDA’s top five approvals in 2022 represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
Madrigal’s NASH drug hits the mark in late-stage trial.
BioCryst Pharmaceuticals is discontinuing the development of its Factor D inhibitor BCX9930 in paroxysmal nocturnal hemoglobinuria due to competitive factors.
Mirati gets the green light from the FDA for its KRAS G12C-mutated lung cancer medication.
In the heated race for a new respiratory syncytial virus vaccine for older adults, Pfizer gained ground on GSK after winning priority review designation for its vaccine candidate.
The FDA has approved Rigel’s Rezlidhia for the treatment of adults with relapsed or refractory AML with a susceptible isocitrate dehydrogenase-1 mutation.
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody, Tecentriq, for metastatic bladder cancer.
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
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