STAT1d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
pharmaphorum1d
FDA panel turns down Acadia's Nuplazid for Alzheimer's psychosis
Nuplazid (pimavanserin) is already FDA-approved to treat psychosis caused by Parkinson's disease, but Acadia's hope to expanding that use to the Alzheimer's population were shot down by a complete ...
Nasdaq14d
Biotech Stocks Facing FDA Decision In February 2025
An FDA panel is scheduled to review Novartis' (NVS) application seeking approval for the expanded use of its drug Fabhalta to treat adults with complement 3 glomerulopathy on February 24 ...
The American Journal of Managed Care10d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Food1mon
Does FDA’s proposed front-of-pack nutrition labeling miss the mark?
Two more minimalistic designs considered were reminiscent of the Nutrition Facts boxes on the back panel and called the amount of specific nutrients in a serving. In the proposed rule, FDA decided ...
FiercePharma28d
Government watchdog recommends tweaks to FDA accelerated approval program
Last year, the FDA granted an accelerated approval to Sarepta’s gene therapy Elevydis after an advisory panel gave it a thumbs up by an 8-6 vote. As for Covis’ Makena, which was approved in ...
JD Supra17d
FDA Releases Proposed Front-of-Package Nutrition Labeling Rule
14 For foods sold from bulk containers, which do not have a principal display panel, FDA proposes that the labeling display the Nutrition Info box plainly in view of the customer at the point of ...