CVM announces a new, CVM-only version of FDAs eSubmitter tool, to be available next month.
FDA accepts a Bristol-Myers Squibb supplemental BLA to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for...
FDA issues a guidance entitled IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human S...
FDA issues a revised International Council for Harmonization guidance on M4E(R2): The CTD Efficacy.
FDA accepts for review a Spectral Medical rolling PMA for Toraymyxin, indicated for treating patients with septic shock.
FDA approves a Teligent ANDA for generic erythromycin topical gel, an antibiotic for treating skin infections.
A House Judiciary subcommittee announces a 7/27 hearing on Antitrust Concerns and the FDA Approval Process.
FDA approves a GlaxoSmithKline supplemental BLA for a new subcutaneous formulation of Benlysta (belimumab) for treating adult patients with active, au...