JD Supra2h
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
SAGE Therapeutics (SAGE) Gets a Hold from Mizuho Securities
In a report released today, Uy Ear from Mizuho Securities maintained a Hold rating on SAGE Therapeutics (SAGE – Research Report), with a price ...
RNA Based Therapeutic Market Growing At A CAGR Of 17.6% From 2025 To 2030.
PORTLAND, IN, UNITED STATES, January 28, 2025 /EINPresswire / -- The RNA based therapeutics has been explored as a promising treatment option for the diseases which are difficult to treat. Development ...
FiercePharma14d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
Sarepta Therapeutics: Guidance Suggests A Year Of Upside Likely
Sarepta Therapeutics' Elevidys for DMD shows revenue potential, with market cap justified at $11.4bn and potential for >50% ...
Becker's Hospital Review14d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
BioWorld15d
OS Therapies heading to FDA with positive osteosarcoma data
The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T ...
kffhealthnews15d
After 2 Deaths, Philips Recalls Software That Mishandled Some EKG Readings
The agency labeled the action a Class I recall, its most serious designation. (Dubinsky, 1/14) Bloomberg: Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says Approvals for drugs from ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.
Mint15d
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal ...
BioSpace15d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena. The Office of the Inspector General at the ...
BioPharma Dive15d
Federal watchdog cites concerns with FDA’s accelerated approval process
It chose the other 14 at random. The office noted that both Aduhelm and Makena are no longer for sale. Exondys, sold by Sarepta Therapeutics, remains on the market, but its required trial to ...