Approvals
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.
The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
ImmunoGen’s Elahere was approved Monday under the FDA’s accelerated pathway for patients who have received one to three previous lines of systemic therapy.
The FDA approved AstraZeneca’s Imfinzi in combination with Imjudo and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer.
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