Federal Register notice: FDA announces a 12/8 Science Board to the FDA Advisory Committee meeting that will hear research needs for evaluating oral ca...
FDA extends by three months the review of a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoie...
FDA asks for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of its Trilogy ventilat...
FDA approves a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes in certain adults an...
FDA Office of Regulatory Affairs Division of Pharmaceutical Quality Operations III program director Jeffrey Meng tells an industry conference that upc...
Pfizer and BioNTech announce results showing that their current authorized bivalent booster vaccine provides a greater increase in neutralizing antibo...
Iovance Biotherapeutics delays its completion of a rolling BLA submission for lifileucel, an investigational tumor infiltrating lymphocyte therapy for...
Federal Register notice: FDA announces a 12/7 public meeting entitled Animal Drug User Fee Act to discuss reauthorizing the user fee program.
