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.
Humanigen Inc. and EVERSANA announced that they are partnering to make lenzilumab available to hospitalized and hypoxic Covid-19 patients in the event that an Emergency Use Authorization is issued from the U.S. Food and Drug Administration and subsequent BLA.
DBV Technologies unveiled a global restructuring plan that will result in a reduction of more than 200 jobs.
Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug somatrogon after the U.S. Food and Drug Administration accepted the companies’ Biologics License Application (BLA) for the therapy.
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration authorized the emergency use of the mRNA vaccine, BNT162b2, against Covid-19 in individuals 16 years of age or older.
New York-based TG Therapeutics announced positive topline results from two global Phase III clinical trials, ULTIMATE I and II, of ublituximab in relapsing forms of multiple sclerosis (RMS).