News

Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...
BioSpace3d
Novo’s Wegovy Inches Closer to Becoming First FDA-Approved GLP-1 Weight-Loss Pill
The FDA accepted Novo Nordisk's NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the ...
Managed Healthcare Executive1d
FDA Sets Goal Date for Antipsychotic Drug, Bysanti
The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.
Accelerating drug discovery with a single carbon atom
A research team from the University of Oklahoma has pioneered a method that could accelerate drug discovery and reduce ...
IPWatchdog21h
Federal Circuit Reverses Injunction Against Avadel Due to Hatch-Waxman Safe Harbor
In a precedential decision issued May 6, 2025, the Federal Circuit reversed in part and vacated in part a Delaware district ...
The Cardiology Advisor22h
FDA Decision on Barth Syndrome Therapy Delayed Again
The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.
US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss
The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...
Wall Street Journal5d
Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
Novo Nordisk NOVO.B2.62%increase; green up 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 tense ...