FiercePharma1d
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 ...
Now that the FDA has banned red dye No. 3, what about more common food dyes?
Following the ban of red dye No. 3 in the United States, experts weigh in on the potential health risks of red dye No. 40, ...
Medpage Today on MSN1d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
BioPharma Dive3d
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 ...
Targeted Oncology1d
FDA Oks Sotorasib/Panitumumab in KRAS G12C-Mutant Colorectal Cancer
The FDA has approved the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for the treatment of patients with ...
STAT9d
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
FDA proposes plan to make cigarettes ‘nonaddictive’ by limiting tobacco
The U.S. Food and Drug Administration has issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco ...
Las Vegas Sun5d
Alternative remedies prescribed as FDA weighs whether to pull plug on drug
Dr. Scott Manthei of the Nevada Ear and Sinus Institute has been advising patients against taking drugs like Sudafed for ...
Winston-Salem Journal2d
FDA takes pivotal step toward reducing nicotine in traditional cigarettes
Nicotine levels would be reduced by up to 95% compared with traditional cigarettes. The U.S. would be the only country with ...
Healio5d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Biden admin plows ahead with 11th hour plan to effectively ban cigarettes
The Biden administration's Food and Drug Administration (FDA) released additional details on a proposed rule that would ...
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 ...