The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.

If istaroxime is granted the new chemical entity designation from FDA, it could provide 7.5 years of U.S. exclusivity and additionally the istaroxime U.S. issued method of use patent protects until ...

Vanda Pharma announces Bysanti NDA with US filing; US FDA decision expected in early 2026: Washington Tuesday, May 6, 2025, 18:00 Hrs [IST] Vanda Pharmaceuticals Inc. (Vanda) anno ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

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 ...

Optimi Health Corp, a manufacturer of GMP-certified MDMA and psilocybin, has received its U.S. FDA Establishment Identifier ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...

For five years, the clinical-stage pharmaceutical company has developed Enbumyst, a nasal spray intended to remove excess ...

The FDA accepted Novo Nordisk's NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the ...

The US Food and Drug Administration (FDA) has accepted Novo Nordisk’s new drug application (NDA) submission for the 25 mg ...

Gold edged higher in Asia amid losses in U.S. stock-index futures. The precious metal's direction is likely to be determined by equities' direction and risk appetite, said Fawad Razaqzada, a market ...

Steven Hatfill promoted hydroxychloroquine during the pandemic. Decades earlier he was wrongly connected with the anthrax ...