GSK and iTeos Therapeutics decide to stop the development of belrestotug, an anti-TIGIT monoclonal antibody for treating certain non-small cell lung c...
Former FDA commissioner David Kessler, who is taking one of the new weight loss drugs, calls on FDA to require data to help people come off the drugs ...
FDA clears a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days...
FDA approves GE HealthCares ultrasound imaging agent Optison 9 for use in pediatric patients.
FDA sends Indian active pharmaceutical ingredient manufacturer Mentha & Allied Products a Warning Letter that cites the firm for significant GMP viola...
FDA and HHS ask public stakeholders for their ideas on regulations that should be eliminated.
FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.
FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of for...
