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...
Assertio Therapeutics agrees to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims abo...
FDA grants Thermosome an orphan drug designation for THE001 and its use in treating soft tissue sarcomas.
