US FDA's drug division chief resigns amid ethics concerns and lawsuit

(Reuters) -The director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, George Tidmarsh, ...

FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct

Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...

FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and ...

Tackling his ADHD kept Jay Glazer in the game – here’s how he helped manage symptoms

Jay Glazer opened his laptop to answer an email. Twenty minutes later, he was scrolling through game footage, texting a producer and looking up a workout routine. The email? Still unsent.

Is your cookware leaching lead? FDA finds more lead-tainted pans. See list.

The FDA has again expanded its warning about cookware that could contaminate food with lead. See the full list of affected ...
New York Post

FDA recalls 16 cinnamon brands with elevated lead levels — here’s what to know

The Food and Drug Administration is recalling 16 brands of cinnamon that contain elevated lead levels, which over time can cause neurological problems including learning disabilities in young children ...
Benzinga.com

FDA Delays Decision Date For Denali Therapeutics' Lead Drug Candidate

The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.’s (NASDAQ:DNLI) review timeline of the Biologics License Application (BLA), seeking accelerated approval of ...
The American Journal of Managed Care

FDA Expands Upadacitinib Label for Treating Inflammatory Bowel Disease

Upadacitinib is now approved for IBD patients unsuitable for TNF blockers after one systemic therapy, broadening treatment options. Clinical trials show upadacitinib's efficacy in achieving remission ...
ophthalmologytimes

FDA clears BVI’s FineVision HP trifocal IOL for the US market

BVI's FineVision HP trifocal IOL, approved by the FDA, enhances the US premium IOL market with advanced optic design for multifocal vision correction. The lens features a diffractive optic design and ...
FiercePharma

Novo plant hit with FDA's most serious inspection classification, portending possible delays for partners

It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time soon. The FDA has tagged the former Catalent facility with an official ...
FiercePharma

FDA adds warning to label of J&J, Legend's Carvykti for potentially fatal intestinal disorder

The FDA has adjusted the label of Johnson & Johnson and Legend Biotech’s Carvykti, warning patients and doctors that use of the multiple myeloma treatment could increase the risk of an intestinal ...
Medscape

FDA Expands Uzedy Indication to Bipolar I Disorder

The FDA has approved an expanded indication for risperidone (Uzedy, Teva) extended-release injectable suspension, allowing it to be used for the maintenance treatment of bipolar I disorder in adults, ...