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

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 ...

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 ...

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 ...

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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 ...

We are encouraged by the FDA approval of a supplemental New Drug Application (sNDA) to expand the breast cancer indication for Ibrance (palbociclib) to include men. While the FDA noted that the ...

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