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 ...
FiercePharma12d
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 Review13d
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 ...
BioSpace13d
Dispatches From JPM, Biogen’s Sage Buyout Offer, Pfizer’s Obesity Play, More
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and ...
BioWorld13d
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 ...
precisionmedicineonline13d
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
BioPharma Dive14d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
kffhealthnews14d
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 ...
BioSpace14d
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, ...
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.