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accelerated approval
Biotech
FDA's Richard Pazdur explains confirmatory trial rejection, more
The FDA's oncology chief also challenged biopharma companies to discuss more simplified trial designs with the agency under Project Pragmatica.
Angus Liu
Apr 8, 2024 6:00am
Sarepta's next DMD drug seems to get the job done in phase 2
Jan 29, 2024 10:49am
Amgen's tarlatamab BiTEs at SCLC in brief readout
Aug 3, 2023 4:01pm
FDA's Marks wants more quick approvals for rare disease drugs
Jul 28, 2023 11:36am
Iovance gets FDA ok for accelerated review of lung cancer drug
Jul 10, 2023 10:40am
FDA needs more time for Sarepta's DMD gene therapy
May 24, 2023 8:39am