Federal Register notice: FDA makes available a draft guidance entitled Bispecific Antibody Development Programs.
FDA approves a Teva Pharmaceuticals ANDA for the first generic naloxone hydrochloride nasal spray (Adapt Pharmas Narcan), indicated for stopping or re...
Pfizer and Eli Lilly report safety concerns with a Phase 3 study comparing tanezumab 2.5 mg and 5 mg with nonsteroidal anti-inflammatory drugs in pati...
FDA gives approval for MediciNova to proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis patients.
FDA approves an Akorn ANDA for a generic copy of Bausch & Lombs Lotemax (loteprednol etabonate) ophthalmic suspension, 0.5%.
FDA clears a Medicrea Group 510(k) for expanded use of its proprietary surgical planning software, UNiD Hub.
Federal Register notice: FDA extends the comment period for a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products.
Federal Register notice: FDA corrects a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products.