FDA says it may relax warning label rule for dietary supplements

Supplements aren’t reviewed for safety and effectiveness, but disclaimers about health benefits are required on products.

Walmart, Target, Kroger failed to remove recalled baby formula linked to 'potentially fatal' illness: FDA

Federal regulators slapped four of the nation’s biggest retailers with warning letters after investigators found recalled ...

FDA mulls strongest safety warning for COVID-19 vaccines

The U.S. Food and Drug Administration is considering adding the strongest safety warning available to COVID-19 vaccines, ...
Medical Marketing & Media

FDA panelists questioned antidepressants in pregnancy. But doctors call them a lifeline.

Medical experts are concerned that a July panel discussion convened by the Food and Drug Administration could lead to more ...
MedTech Dive

FDA needs more staff, authority to oversee device recalls, watchdog finds

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and ...

FDA announces recall on salad dressings sold in 27 states, including Oklahoma

The U.S. Food and Drug Administration announced a recall for thousands of gallons of salad dressings and condiments sold at popular grocery stores, including ce ...
Tri-State Livestock News

FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick

Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the ...
CURE

FDA Approves Enhertu Plus Perjeta in Advanced HER2+ Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with ...

Chaos At The FDA Benefits America’s Rivals—At The Expense Of America’s Patients

If the FDA ceases to be a predictable source of regulatory guidance, then China will gain a significant advantage in the race ...
CURE

FDA Grants Breakthrough Designation to INCA-33989 in Essential Thrombocythemia

The FDA has granted breakthrough therapy designation to INCA033989 for some patients with essential thrombocythemia.

Roche Gets Expanded FDA Approval for Breast-Cancer Test

Roche received expanded approval from the Food and Drug Administration for a test to diagnose breast cancer. The pharmaceutical company said Monday that the FDA approved the PATHWAY HER2 (4B5) test ...