Eli Lilly and Regeneron are among the first seven companies the FDA has selected for its PreCheck Pilot Program, CNBC has ...
The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
The U.S. Food and Drug Administration (FDA) recently launched a drug repurposing initiative that may signal a shift in how ...
The U.S. Food and Drug Administration has selected Eli Lilly and Regeneron , among seven companies, for a pilot ...
Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Mark your calendar: June 30, 2026 (10:00 a.m. PDT). A 37.5% ownership interest in ...
The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...
Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
Shares of Regenxbio plunged after the Food and Drug Administration placed clinical holds on two drug development programs after a five-year-old participant in one study developed an intraventricular ...
Yesterday afternoon, Neuren Pharmaceuticals Ltd (ASX: NEU) shared feedback from recent US FDA meetings on its NNZ-2591 clinical programs. Neuren said it received constructive guidance for its ...
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