Dietary supplement makers push the FDA to allow peptides and other new ingredients

It’s the first such meeting since Robert F. Kennedy Jr. became the nation’s top health official last year. Kennedy has vowed ...
STAT

FDA approves Rocket gene therapy for rare immune disorder

The Food and Drug Administration approved on Thursday a gene therapy for severe leukocyte adhesion deficiency type 1 (LAD-1), ...

FDA warns biotech firm over cancer drug claims

The U.S. Food and Drug Administration (FDA) has warned a biotech company about claims that its bladder cancer drug could treat and prevent multiple types of cancer.

FDA opens door to feedback on ‘unclear’ national priority voucher pathway

"FDA opens door to feedback on ‘unclear’ national priority voucher pathway" was originally created and published by ...
Healio

FDA approves once-weekly basal insulin for adults with type 2 diabetes

The FDA approved a once-weekly, long-acting basal insulin for adults with type 2 diabetes as an alternative to daily basal ...

Pasta recall update as FDA sets highest risk level

Class I recalls indicate a probability that use of or exposure to the product will cause serious adverse health consequences.

Rocket’s gene therapy Kresladi wins FDA approval in rare immune disease

Upon approval, Rocket has been awarded a priority review voucher, which currently fetch around $200m on the secondary market.
MedPage Today on MSN

FDA signals regulatory flexibility with accelerated approval of rare disease drug

Tividenofusp alfa is the first approved treatment for neurologic complications of Hunter s ...

FDA issues highest-level recall for peeled garlic sold in US: ‘Health problems or even death’

The Food and Drug Administration has issued its most serious recall for peeled garlic sold in New York, Vermont and Pennsylvania over a potential botulism risk. The Class I recall is for Christopher ...
Fierce Pharma

Rocket plots measured trajectory for new gene therapy Kresladi after clearance to launch from FDA

With an end-of-week green light from the FDA, Rocket Pharmaceuticals has officially broken into commercial orbit.  | Rocket ...

Peeled Garlic Recalled by FDA for Possible ‘Serious Adverse Health Consequences or Death,’ Marking Highest Warning Level

“Eating the food may cause health problems or even death,” warned supermarket chain Tops Friendly Markets ...

FDA says billionaire's claims about cancer drug Anktiva are misleading

Federal health officials posted a warning about misleading statements by biotech billionaire Dr. Patrick Soon-Shiong about ...