Amgen rejects an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to concerns related to clinical trial adjudication and liver safety.
Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from being added to FDA’s new expedited review voucher program.
Amgen rejects an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to concerns related to clinical trial adjudication and liver safety.
Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from being added to FDA’s new expedited review voucher program.
Three Hogan Lovells attorneys analyze the new FDA medical device inspection compliance program and caution manufacturers to begin working on the significant changes it will require.
Three drug trade associations give FDA their perspectives on increasing access to nonprescription drugs.
