Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...

President Donald Trump’s pick to lead the US Food and Drug Administration told senators in a tense confirmation hearing ...

Receives FDA authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study of ENTR-601-44 in adults living with ...

for this you must simply complete and return the duplicate savings certificates form to the post office which issued you the NSC which is needed to be replaced. The National Savings Certificate is a ...

Hundreds of children with a rare and severe form of epilepsy are hoping a new drug being rolled out on the NHS may provide a better quality of life. Fenfluramine has been recommended by the ...

Piramal Pharma slipped 1.14% to Rs 195.40 after the US FDA issued a Form-483 with 6 observations to the company's Turbhe facility post a GMP inspection. In a regulatory filing made after market hours ...

TUESDAY, Feb. 18, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA). The new tablet is ...

Launch Establishes Evolus as a Multi-Product Performance Beauty Company and Expands Addressable Market by 78% Evolus plans to launch Evolysse ™ Form and Evolysse ™ Smooth in the U.S. market in Q2 2025 ...