Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration (FDA) pathway allows promising new cancer agents to reach the market, and patients, sooner. But ...
“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement ...
A report showed that in cancer drug indications that received FDA accelerated approval, demonstrated high clinical benefits correlated with shorter times to subsequent full approval. Nearly a quarter ...
The HHS Office of Inspector General report emphasizes the need for better documentation and oversight in the FDA's accelerated approval pathway. The accelerated approval pathway is crucial for ...
SAN DIEGO, June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide ...
Nath stated, "We plan to meet with the FDA to discuss these results and explore next steps in getting COMP360 to patients as rapidly as possible." Loxam reiterated, "We are finalizing a PTSD study and ...
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