The FDA has approved a generic form of fluticasone propionate inhalation aerosol (Flovent HFA) as a prophylactic maintenance treatment for asthma, the agency announced on Tuesday.

BioMarin’s Voxzogo (vosoritide) won FDA approval in paediatric achondroplasia in November 2021 and secured a label extension ...

On Friday, the U.S. Food and Drug Administration (FDA) approved BioMarin Pharmaceutical Inc.’s supplemental application for ...

Ascendis Pharma A/S (NASDAQ:ASND) executives outlined plans for the U.S. launch of YUVIWEL following FDA approval, describing the product as the first once-weekly treatment for children with ...

Ascendis Pharma A/S shares are up during Monday’s premarket session following the FDA’s approval of Yuviwel (navepegritide; ...

The approval follows PEGASUS Phase III trial assessing Palynziq efficacy and safety compared to diet alone in adolescents ...

Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...

Ascendis Pharma is spiraling upward by way of its TransCon platform. | Ascendis Pharma is spiraling upward by way of its TransCon platform. For the third time in six years, the Copenhagen-based ...

FDA PMA establishes Claire as the first AI-integrated imaging device indicated for real-time intraoperative margin assessment during breast-conserving surgery. Re-excision remains ~20% nationally, ...

The FDA has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis.

The FDA granted full approval encorafenib (Braftovi) in combination with cetuximab (Erbitux) and fluorouracil-based ...

The U.S. Food and Drug Administration (FDA) has issued warning letters to 30 telehealth companies citing false or misleading claims about compounded GLP-1 weight-loss products on their websites. The ...