FDA asks manufacturers of OTC teething aids containing benzocaine to pull them from the market or face regulatory action to force them out.
FDA issues a guidance on developing drugs with an indication of prophylaxis to inhalational anthrax in certain persons.
The Solicitor General tells the Supreme Court the government believes the court should hear Mercks appeal of a Fosmax failure-to-warn case.
Federal Register notice: FDA makes available a guidance entitled Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Applicat...
Federal Register notice: FDA makes available a draft guidance for industry entitled Maximal Usage Trials for Topical Active Ingredients Being Consider...
FDA approves an Eli Lilly supplemental NDA for a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the gen...
FDA issues a complete response letter recommending an additional Phase 3 trial of Cosmo Pharmaceuticals Methylene Blue MMX coloring agent.
FDA accepts for review a Sanofi NDA for Zynquista (sotagliflozin), an oral treatment added to insulin therapy to improve blood sugar control in adults...