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 ...
On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program. The 22-page guidance ...
“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 ...
The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall ...
The HHS OIG report calls for improved FDA oversight of the accelerated approval pathway, focusing on timely confirmatory trials and financial impacts on Medicare and Medicaid. Chelsee Jensen ...
~ FDA agrees that the composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval ~ As part of uniQure’s Regenerative Medicine ...
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 ...
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