Medscape

Accelerated Approval Pathway for Cancer Drugs: Does It Work?

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 ...
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On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program.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 ...
FiercePharma

FDA's accelerated approval pathway needs stronger transparency, evidence standards: ICER

The FDA should strengthen the evidence required for drug approvals under its accelerated pathway and increase transparency surrounding those regulatory decisions, according to a report (PDF) from a ...
Business Wire

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

LILLE, France & PARIS--(BUSINESS WIRE)--4Moving Biotech (4MB), a clinical-stage biotechnology company developing next-generation Disease-Modifying Osteoarthritis Drugs (DMOADs), today announced that ...
RAPS

FDA: Genome editing therapies may use accelerated approval pathway

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors developing gene therapy products that incorporate genome editing (GE) of human somatic cells; the final version ...
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 ...
Business Wire

Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in Fabry Disease With BLA Submission Expected in 2025

- 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 ...
Morningstar

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

FDA Fast Track Designation granted to 4P004 for the treatment of knee osteoarthritis, recognizing the disease as a serious condition with significant unmet medical need Designation supports enhanced ...