Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at zero, one, and six ...
Tags: Medicine, Emergent BioSolutions, Anthrax Vaccine Adsorbed
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...
Sanofi and Regeneron Pharmaceuticals have received FDA priority review for the biologics license application (BLA) of ZALTRAP (aflibercept) as a treatment for metastatic colorectal cancer (mCRC). The filing was based on the Phase III ...