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 ...
Yahoo Finance

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral ...
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 ...
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

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 ...
Seeking Alpha

Compass Pathways outlines FDA engagement and accelerated pathways for COMP360 in TRD while advancing PTSD program

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 ...