A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

Secretary of State Marco Rubio embarks on his first foreign trip, focusing on immigration, drug trafficking, and reclaiming U.S. control over the Panama Canal amid concerns over China's growing ...

Chimerix stock surges 324% in three months following NDA submission for high-grade glioma drug, dordaviprone, for accelerated ...

Ad hoc announcement pursuant to Art. 53 LR Full year Net sales grew +12% (cc1, +11% USD) with core operating income1 up +22% (cc, +19% USD) Sales growth driven by continued strong performance ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for SL1009 (sodium dichloroacetate oral solution) for the treatment of pyruvate dehydrogenase complex ...

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

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The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...

The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.