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 ...
MPR12h
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 ...
Managed Healthcare Executive3d
FDA Sets Action Date for Oral Wegovy for Weight Loss
A decision is expected in the fourth quarter of 2025.
Targeted Oncology3d
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 ...
Orange County Business Journal17h
Corstasis Says Spray Reverses Heart Failure Side Effect
For five years, the clinical-stage pharmaceutical company has developed Enbumyst, a nasal spray intended to remove excess ...
CURE9d
FDA OKs Investigational New Drug Application for VS-7375 in Solid Tumors
Verastem will launch a U.S. phase 1/2a trial of oral KRAS G12D inhibitor VS-7375 after FDA IND clearance, with data to be ...
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 ...
BioPharma Dive7d
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 ...