FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for pheny...
FDA approves the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the treatment and preven...
The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.
HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical evidence.
FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for T...
Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.
FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical device...
Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients...
