Tag Archives: FDA

The FDA is warning the public about possibly radioactive shrimp that may have been sold at Walmart in 13 states. The warning is for some Great Value raw frozen shrimp because it may be contaminated with Cesium-137, a radioactive isotope, the FDA announced on Tuesday. The products include the following product names, lot codes, and best by dates: Great Value …

Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer  Merck.comView Full Coverage on Google News Source link

Gilbert Dryden probably only has enough medication to get him through the end of October, his mother, Madison, figures. Seven-month-old Gilbert has a rare genetic condition called Barth syndrome, one that can have dire consequences, like heart failure, extreme muscle weakness and a dramatically reduced life expectancy. Children who die early often don’t see their fifth birthday. Two infant deaths …

On Friday, the U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals Holding Corp.’s (NASDAQ:TNXP) Tonmya (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults. Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, and other symptoms like sleep disturbances and cognitive difficulties. Tonmya is a non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is …

WASHINGTON (AP) — When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence, credentials and judgment. But increasingly, the agency isn’t calling them. Instead, FDA Commissioner Marty Makary has launched a series of ad hoc “expert panels” to discuss antidepressants, menopause …

US FDA approves Tonix Pharma’s drug to manage pain related to chronic condition  Reuters Tonix Pharmaceuticals Holding Second Quarter 2025 Earnings: Misses Expectations  Yahoo Finance With FDA nod, Tonix’s Tonmya becomes first new fibromyalgia treatment in more than 16 years  Fierce Pharma Anticipating TNX-102 SL’s Addition to the Fibromyalgia Toolkit, with Andrew Sharobeem, DO  HCPLive Tonix Pharmaceuticals stock halted ahead of FDA approval news  Investing.com …

Novo Nordisk wins FDA label expansion for Wegovy against liver disease MASH  Seeking Alpha Novo Nordisk’s Wegovy gets accelerated US approval for liver disease MASH  Reuters Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis  PR Newswire Novo Nordisk A/S: Wegovy® approved in the US for the treatment of MASH  Yahoo Finance Novo Nordisk’s obesity …

Tonix Pharmaceuticals (Nasdaq: TNXP) has received FDA approval for Tonmya™, a groundbreaking treatment for fibromyalgia in adults – the first new therapy approved in over 15 years. This non-opioid, sublingual tablet is designed for once-daily bedtime use with rapid bloodstream absorption. Two pivotal Phase 3 clinical trials involving nearly 1,000 patients demonstrated …

Five cheese products have been urgently recalled due to being potentially contaminated with deadly bacteria and rodents. Wegmans Food Markets has voluntarily recalled four of its cheese products containing camembert and brie cheese after they were found to be at risk of containing listeria, a type of bacteria that causes severe diarrhea and muscle aches. The recall included the following products: …

An unusual about-face that played out at the Food and Drug Administration over the last week illustrated the power of the “Make America Healthy Again” movement, particularly with its focus on “natural” drugs. Last Thursday, the agency published a statement saying it had concerns about the safety and effectiveness of unapproved thyroid medications made from animal tissue after it received …