FDA approves first rapid-acting insulin biosimilar for patients with diabetes
Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...
Reuters6d
US FDA approves GSK's combo meningococcal vaccine
In 2023, there were 438 confirmed and probable cases of meningococcal disease reported in the United States, according to the U.S. Centers for Disease Control and Prevention. Cases of ...
Teva and Alvotech get FDA review acceptance for its proposed biosimilar to Eylea
Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...
Ezra Announces New FDA Clearance, Enhancing the Capabilities of Its Full-Body Scan Technology
Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...
PolarityBio Receives U.S. FDA Breakthrough Therapy Designation for Treatment of Wagner Grade I Diabetic Foot Ulcers (DFU)
The FDA has granted Breakthrough Therapy Designation for SkinTE based on key positive data from the Phase II study in Wagner1 DFUs highlighting ...
STAT9h
Dozens of attorneys general urge FDA to crack down on counterfeit obesity drugs
More than three dozen attorneys general are urging the FDA to take “decisive action” against counterfeit obesity drugs.
Endocrinology Advisor1d
FDA Approves Merilog, a Rapid-Acting Insulin Biosimilar Product
The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog, to improve glycemic control in patients with diabetes mellitus.
Raisin Recall Update As FDA Sets Most Serious Risk Level
The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some people with ...
Grail projects FDA submission completion for Galleri by H1 2026 with expanded scalability
Discover how Grail Inc. achieved 45% revenue growth, improved scalability with the updated Galleri test, and navigates legislative and market challenges.
scmp.com5d
FDA approves GSK vaccine to combat meningococcal infections
The US Food and Drug Administration (FDA) approved British drug maker GSK’s combination vaccine to protect against meningococcal infection for use in people aged 10 through 25 years, the company ...
Today5d
Granola bar recall: FDA updates recall for over 2 million MadeGood granola bars
The U.S. Food and Drug Administration has made an update to its MadeGood granola bar recall. The popular granola bars, sold on Amazon and in stores like Target, Whole Foods, Wegmans, CVS, among ...
What’s the Difference Between the FDA and the USDA?
Explaining America’s weirdly complicated food inspection system, including who regulates poultry and eggs and how Robert F. Kennedy Jr. is involved ...