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 ...
BioSpace1d
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 ...
Medindia3d
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® ...
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 ...
Targeted Oncology4d
FDA Actions in Oncology: April 2025 Approvals and Designations
A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is for ...
MPR1d
Milsaperidone Under Review for Bipolar I Disorder and Schizophrenia
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...
Rheumatology Advisor7h
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.
BioPharma Dive8d
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
Wall Street Journal3d
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 ...