FDA publicly releases an 11/4 complete response letter issued to Biohaven on its NDA seeking approval for troriluzole to treat spinocerebellar ataxia.
FDA extends by three months its review of Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) and its use in treating acquired hypoth...
FDA releases the form FDA-483 with six observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany...
FDA publishes 76 new and revised product-specific guidances intended to speed generic drug development and approval.
The Trump Administration announces new agreements with Eli Lilly and Novo Nordisk to lower U.S. prices for several products, including the GLP-1 medic...
FDA announces six additional drugs awarded Commissioners National Priority vouchers.
FDA warns 18 Internet companies that they are illegally selling Botox products.
An Obesity Action Coalition survey finds that people want FDA and drug companies to change the way that obesity drugs are tested and labeled.
