FDA releases its latest batch of Warning Letters that includes Lupin Limited, Shanghai Institute of Pharmaceutical Industry, Dermameal, and Galt Pharm...
Heron Therapeutics resubmits an NDA for HTX-011, an investigational agent for managing postoperative pain.
Former FDA commissioner Robert Califf accepts a full-time role at Alphabet Company as the head of medical strategy and policy for Google Health and Ve...
FDA clears a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for detecting methicillin...
FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listing it as a manufactu...
Four pharmaceutical stakeholders suggest edits to the FDA BEST glossary of biomarker, endpoints, and other tools.
AstraZeneca says it will work closely with FDA on next steps after receiving a complete response letter for its PT010 experimental COPD drug.
Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal year 2020.