North Carolina biotech sues to block copies of $400M drug
BioCryst Pharmaceuticals sues Hetero with claims of Orladeyo patent infringement. Orladeyo generated $437.7 million in revenue for BioCryst last year. BioCryst seeks court order to prevent FDA ...
The limits of RFK Jr.’s power
HHS doesn’t have oversight over all food and nutrition products and policies. Nor does the Food and Drug Administration, ...
Raleigh Whole Foods remove recalled item from the shelves for a ‘life-threatening’ reason
People who have egg allergy may experience a “serious or life-threatening allergic reaction” if they eat the product, the ...
NC Biotech6d
Doron’s biologic osteoarthritis treatment gets FDA boost
Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...
NC Biotech2d
NCBiotech's Sara Imhof honored by Triangle Business Journal
Sara Imhof, Ph.D., vice president of the focused initiatives team at the North Carolina Biotechnology Center, has been honored by a regional business publication for her inspiring work to lead North ...
FDA, HHS announce plans to increase testing for heavy metals, contaminates in baby formula
The FDA and HHS announced "Operation Stork Speed" Tuesday, which aims to increase testing for heavy metals and other ...
Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...
Scientific American5d
Scientist’s Study Led FDA to Ban Red No. 3 Food Dye. Yet He Says It Is Safe
Joseph Borzelleca published a study on the food coloring Red No. 3. The FDA cited his work when banning the additive in ...
FDA allows companies to decide what food additives are safe. That may be changing.
The Food and Drug Administration lets companies self-report whether a chemical they add to food is safe. That may be changing ...
The FDA has recalled some raw cat food — here’s what’s safe to give your pet instead
This weekend, the FDA announced that two types of Savage Pet raw cat food are being recalled for potential contamination with ...
Opus Genetics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biopharmaceutical company developing important new therapies ...
PhillyVoice5d
How the FDA opens the door to risky chemicals in America's food supply
Food manufacturers often are left to decide whether their ingredients and additives are safe. Experts say hundreds of products contain chemicals linked to health concerns.