BioPharma Dive2d
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 ...
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
Becker's Hospital Review2d
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 ...
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 ...
BioSpace2d
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, ...
Business Wire4d
Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024
SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by ...
Ozempic, Wegovy among drugs selected for Medicare's price negotiations
The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...
Newsom committed California to making its own insulin. It’s at least a year behind his schedule
Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is ...
New FDA rule to boost OTC drug access, but self-screening required
Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).