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.
Senator Bernie Sanders (I-VT) looks to become chairman of the Health, Education, Labor and Pensions (HELP) Committee after current chair Patty Murray ...
FDA issues an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by pharmacists that are ...
Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they told the agency the products were no longer marketed.
CDER lead consumer safety officer Leyla Rahjou-Esfandiary says the agency wants to receive comments by 11/22 on its proposal to increase the National ...
