JD Supra

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program.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 ...
The American Journal of Managed Care

Price Caps During Accelerated Approval Would Help Address Financial Toxicity for Patients, Jensen Says

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 ...
Nasdaq

uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease

~ 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 ...
Nasdaq

Avidity Biosciences Announces the Accelerated Approval Regulatory Pathway in the U.S. is Open for Del-Brax and Initiates the Global, Confirmatory Phase 3 FORWARD™ Study in FSHD

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 ...
MedPage Today

Skepticism Hangs Over Cancer Drugs Stuck With Accelerated Approval for Years

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 ...