The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

Qure advances its Huntington’s program toward accelerated approval as PTC Therapeutics reports strong Phase 2 results. Learn ...

Top-line results from two pivotal Phase III trials found that MR-107A-02 significantly reduced pain intensity following ...

In a precedential decision issued May 6, 2025, the Federal Circuit reversed in part and vacated in part a Delaware district ...

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

The product, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths, is the generic equivalent of Sumitomo Pharma ...

The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...

action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified ...

Novo Nordisk NOVO.B-3.93%decrease; red down pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a ...