The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.

Johnson & Johnson announced the U.S. FDA approval of a supplemental New Drug Application for Spravato CIII nasal spray, making this innovative treatment the first and only monotherapy for adults ...

Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...

Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, and the European Medicines Agency, EMA, has validated ...

Merck, known as MSD outside of the United States and Canada, announced the US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking ...

Exelixis, Inc. (NASDAQ:EXEL), a biopharmaceutical company with a market capitalization of $9.4 billion focused on developing and commercializing novel therapies for cancer treatment, stands at a ...

London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves ...

A supplemental New Drug Application (sNDA ... The drug development process is inherently risky, with the potential for setbacks at various stages. Negative trial results or safety concerns ...

Our thesis is that Sublocade’s weakness would prove temporary as Indivior has filed a supplemental new drug application (sNDA) for an improved dosing regimen. We believe this new dosing regimen ...