The U.S. Food and Drug Administration granted marketing clearance for Ryplazim as the first FDA-approved therapy for the treatment of patients with the plasminogen deficiency type 1 (hypoplasminogenia), a rare genetic disorder.
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).
Iovance Biotherapeutics faces another delay in the company’s biologics license application (BLA) submission for lifileucel, as the U.S. Food and Drug Administration once again requested additional data on the tumor-infiltrating lymphocyte (TIL) therapy candidate’s potency assays.
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.
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.
The U.S. Food and Drug Administration extended the review period for Biogen and Eisai’s Biologic License Application (BLA) for aducanumab for Alzheimer’s disease.
As the 2021 virtual J.P. Morgan Healthcare Conference wrapped up, BioSpace reviewed news from companies regarding their deals, pipeline and regulatory updates.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.