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FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...[ Price : $8.95]
Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from...[ Price : $8.95]
The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.[ Price : $8.95]
HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical ...[ Price : $8.95]
FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi su...[ Price : $8.95]
Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.[ Price : $8.95]
FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate developme...[ Price : $8.95]
Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignati...