Novavax files an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.
FDA posts a final guidance entitled Diabetic Foot Infections (DFI): Developing Drugs for Treatment.
FDA approves an expanded use for Amgens Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with lymphoblastic leukem...
FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.
The U.S. Supreme Court 6/13 unanimously rejects a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Dancos ...
FDA updates its advice on this falls Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S.
Pfizer says that its Phase 3 CIFFREO placebo-controlled study evaluating an investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec...
Federal Register notice: FDA issues an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a person that has an ...