District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking ...

FDA proposes draft guidelines on AI use in drug development, addressing challenges and opportunities for improving safety and ...

Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...

The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...

FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...

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Public health experts worry the FDA workforce will be slashed, impeding the ability of the agency to review new medicines ...

according to an FDA document (PDF). The drug was approved by the agency in 2023 as a treatment for paroxysmal nocturnal hemoglobinuria, winning the title of the first oral monotherapy approved for ...

Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous PolyposisUnderscores unmet need for a ...

At this time, I'd like to welcome everyone to the Biogen fourth-quarter and full-year 2024 earnings call and business update. (Operator Instructions) Today's conference is being recorded. Thank you. I ...

Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC. Amezalpat builds ...

Portfolio Receipts of $742 million in Q4 2024 and $2,801 million for FY 2024Royalty Receipts growth of 12% in Q4 2024 and 13% for FY 2024 Net ...