The challenge is that unlike clinical outcomes and drug tolerability ... chart review studies, there are some exceptions. The need for informed consent can prolong study timelines as well as ...

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

A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

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

today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG ® (belzutifan), Merck’s oral hypoxia ...

People considered public safety and national security threats are still the top priority, Elliston said ... including the FBI, the Drug Enforcement Administration and the Bureau of Alcohol ...

The starting date of the timeline is dependent on financing, which may be completed in whole or in part. The reference date ranges provided are not guaranteed and may be adjusted due to financial ...

The contracting and approval processes with clinical study sites are a planned priority, and their timelines are expected ... module for submission to the FDA for approval of IzoView.

The FDA will carry out a speedy review of Sanofi and Sobi's once-weekly haemophilia A treatment efanesoctocog alfa (Bivv001), with a decision now expected by 28 February next year.