Seeking Alpha

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

DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study ...
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 ...
STAT

Bashing accelerated approval isn’t supported by the data

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 ...
Hosted on MSN

Navigating the FDA’s accelerated approval pathways for oncology drugs

“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 ...
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 ...
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 ...