News

Rare Disease Industry Awaits FDA Chief’s New Drug Pathway Plan
FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...
STAT3hOpinion
How to stop the shift of drug discovery from the U.S. to China
U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...
Atara Biotherapeutics Says FDA Lifts Clinical Hold
Atara Biotherapeutics said a clinical hold on its new drug applications for its Ebvallo tabelecleucel program to treat Epstein-Barr virus by has been lifted by the Food and Drug Administration. The ...
The Marijuana Herald14h
Optimi Health Secures FDA Registration to Supply MDMA and Psilocybin Across the U.S.
Optimi Health Corp, a manufacturer of GMP-certified MDMA and psilocybin, has received its U.S. FDA Establishment Identifier ...
MPR16h
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 ...
Orange County Business Journal20h
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 ...
Pharmaceutical Technology on MSN1d
FDA accepts Novo Nordisk’s NDA submission for weight management therapy
The US Food and Drug Administration (FDA) has accepted Novo Nordisk’s new drug application (NDA) submission for the 25 mg ...
Scientist who was part of covid treatment controversy returns to HHS
Steven Hatfill promoted hydroxychloroquine during the pandemic. Decades earlier he was wrongly connected with the anthrax ...
Novo Nordisk Says FDA Accepts New Drug Application for Wegovy Pill — Update
Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on the ...
Managed Healthcare Executive3d
FDA Sets Action Date for Oral Wegovy for Weight Loss
A decision is expected in the fourth quarter of 2025.
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 ...
Novo Nordisk says oral version of Wegovy accepted for FDA review
Novo Nordisk (NVO) stock in focus as oral Wegovy is accepted for FDA review for chronic weight management. Read more here.