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

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

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

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 the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.

Pharming has agreed a deal to sell a recently awarded priority review voucher (PRV ... that Pharming was granted the PRV by the FDA after it claimed approval for Joenja (leniolisib), a therapy ...

The FDA has started a priority review of AstraZeneca and Amgen's severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. If approved, TSLP inhibitor ...

The partners expect the FDA to complete its review process ... granted priority review to the company’s new drug application. The company is specifically going after an approval to treat locally ...

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