Piramal Pharma shares in focus after US FDA issues six observations for Mumbai facility
Piramal Pharma shares will be in focus after the US FDA's GMP inspection at its Turbhe facility from February 11-17, 2025, ...
FDA’s food safety head resigns over mass layoffs
Jim Jones, the head of the Food and Drug Administration’s (FDA) food division, resigned Monday, citing the mass firings of ...
STAT16h
Biogen partners with Stoke Therapeutics to sell severe epilepsy drug
From my colleague Adam Feuerstein: Biogen and Stoke Therapeutics have signed a partnership agreement to co-develop and sell ...
Hologic announces FDA clearance of Aptima SARS-CoV-2 assay
Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency ...
MMJ Marijuana Waiting FDA Approved Huntington's Clinical Trials As RFK Jr.'s Push to Conduct Scientific Research
MMJ's innovative soft gelatin THC-CBD capsule, known as MMJ-002, is undergoing the rigorous FDA approval process to ...
complianceg1d
Be Prepared for Your Journey with The FDA – How to Be Inspection-Ready
Ensure your FDA inspection readiness with expert guidance! Learn how to navigate audits, maintain compliance, and implement effective CAPA strategies.
The Register-Herald21d
Fear hits east Jerusalem as Israel moves to close UN Palestinian refugee agency
JERUSALEM (AP) — In the Shuafat refugee camp, a hardscrabble district in east Jerusalem surrounded by a concrete wall, cars inched their way toward an Israeli checkpoint. Intense security makes ...
CNN21d
FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.
Newsweek21d
Broccoli Recall Update as FDA Sets Highest Risk Level Over Bacteria Fears
Broccoli florets sold in Walmart stores across 20 states that were recalled over bacterial contamination fears have been given the U.S. Food and Drug Administration (FDA)'s highest risk level.
Acsh.org22d
FDA’s Failures in the Infant Formula Debacle Cry Out for Reform
An audit released by the Inspector General of the U.S. Department of Health and Human Services, the parent organization of the Food and Drug Administration (FDA), is not a pleasant read. Let us turn ...
medtechdive23d
FDA webpages on clinical trial diversity removed after Trump orders
It’s not clear if the changes are temporary or if the pages will be restored. When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and ...
PBS24d
The FDA banned Red 3 food coloring. A scientist explains the dye’s history and health risks
Red 3 – also called FD&C Red No. 3, erythrosine or E127 – has been widely used in food, cosmetics and pharmaceuticals since its FDA approval in 1969. You’ve likely encountered Red 3 before.