FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for T...
Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new Quality Management S...
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.
Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from HHS, FDA and CDC re...
FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immunogenicity and its i...
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...
