The U.S. Food and Drug Administration extended Legend Biotech Corporation’s Prescription Drug User Fee Act (PDUFA) target date for the drug cilta-cel that the company is developing with partner Janssen Biotech to treat relapsed and/or refractory multiple myeloma.
The U.S. Food and Drug Administration accepted for filing the New Drug Application submitted by Acer Therapeutics Inc. and the company’s collaboration partner Relief Therapeutics Holding SA for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders.
Shares of Verrica Pharmaceuticals plunged after the company received a Complete Response Letter from the U.S. Food and Drug Administration for an experimental treatment for molluscum contagiosum (molluscum).
The U.S. Food and Drug Administration accepted for review a Biologics License Application (BLA) for the anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy.
Shares of Provention Bio Inc. plunged in trading after a Food and Drug Administration advisory committee narrowly supported the company’s diabetes prevention drug, teplizumab.
The U.S. Food and Drug Administration accepted for priority review the Biologics License Application submitted by Janssen Biotech Inc. for ciltacabtagene autoleucel (cilta-cel). The investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy is intended for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to Biogen’s experimental drug aducanumab for Alzheimer’s disease in a JAMA article.
The U.S. Food and Drug Administration accepted for Priority Review Pfizer Inc.’s Biologics License Application for TicoVac, the company’s tick-borne encephalitis vaccine for active immunization to prevent TBE in individuals 1 year of age and older.
Bristol Myers Squibb reported that the company was abandoning the BCMA CAR-T therapy orva-cel and taking a $470 million write-off.
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for the company’s treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).