News

US FDA advisers vote against Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its ...
US FDA advisers recommend against Otsuka's PTSD combination treatment
The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination ...
Juul gets FDA approval to keep selling e-cigarettes
FDA regulators said Thursday that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit ...
FDA recalls frozen sprouted beans produced by Sugarland company for links to salmonella outbreak
Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a ...
FDA plans to revoke 52 food standards
The U.S. Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they are "obsolete ...
The FDA Announces Recall on Bread Sold at Walmart and Kroger in These States
Lewis Bake Shop is issuing a voluntary recall on their Artisanal Style 1/2 Loaf, which contains undisclosed hazelnuts — a ...
Health Cuts Would Result in Fewer Drugs for Americans, Budget Office Reports
The Trump administration’s proposed cuts to medical research and health agencies will curtail the development of promising ...
FDA to change 52 food standards
The FDA just proposed 52 food regulation changes — but you probably haven’t noticed why. 遼拏 One dietitian says the real issue isn’t what’s changing: ...
BioPharma Dive6h
Panel urges FDA to remove warnings on hormonal menopause therapy
A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...
CSP Daily News4h
FDA, FTC warn companies for illegally selling Delta-8 products
Delta-8 is a substance found in the cannabis sativa plant, of which marijuana and hemp are two varieties, the agency said.
CURE7h
FDA Grants Priority Review to TAR-200 for Bladder Cancer Subset
FDA grants priority review to TAR-200, which demonstrated an 82% complete response in high-risk bladder cancer unresponsive ...