News

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 Herald10h
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 ...
MPR11h
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 Journal16h
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 ...
Fierce Pharma17h
BioNTech, gearing up for cancer drug approval filing, works to diversify supply base
As BioNTech progresses with its goal to grow into a “fully integrated immunotherapy powerhouse,” the German biotech is e | ...
FDA clears OBI Pharma’s IND to begin Phase I/II solid tumour trial
OBI Pharma has received clearance from the US Food and Drug Administration (FDA) for an investigational new drug (IND) ...
The Manila Times20h
BioCryst Reports First Quarter 2025 Financial Results and Provides Business Update
RESEARCH TRIANGLE PARK, N.C., May 05, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported ...
Pharmaceutical Technology on MSN22h
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 ...
Pharmabiz23h
US FDA accepts Novo Nordisk’s NDA submission for oral semaglutide 25 mg for treatment of obesity
Plainsboro, New Jersey Monday, May 5, 2025, 14:00 Hrs [IST] ...