Hosted on MSN11m
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.
BioPharma Dive15m
ALS drugs from Denali, Calico come up short, marking setback for Healey trial
Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the ...
JD Supra48m
FDA Approves Celltrion’s STEQEYMA (ustekinumab-stba)
According to Celltrion, STEQEYMA is expected to be marketed in the United States beginning in February 2025. DISCLAIMER: Because of the generality of this update, the information provided herein may ...
medtechdive54m
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
Pet food recall: Stop using this product immediately
Do not sell or donate the recalled products, and do not feed the recalled product to pets or any other animals. Wash and ...
What RFK Jr.'s War on Corn Syrup Could Mean for Your Grocery Basket
Robert F. Kennedy Jr.'s plan to combat obesity and chronic diseases by targeting high-fructose corn syrup could mean changes ...
Cheddar cheese listeria recall hits several states: FDA says avoid these Wicklow Gold products
New Jersey-based Abbey Specialty Foods is recalling cheddar cheese products due to fears of listeria contamination. Here’s ...
JD Supra2h
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
Quality Assurance3h
FDA Issues Final Guidance on Action Levels for Lead in Processed Food Intended for Babies, Young Children
The final guidance covers packaged processed foods that are represented or purported to be for babies and young children less ...
Pet food recall: Do not feed this to your pets, throw away ASAP
The Massachusetts Department of Agricultural resources discovered the contamination after a customer reported a sick animal.
Doctors warn: Supplements may do more harm than good
Millions of people take supplements daily, but experts warn they could do more harm than good. Here's what doctors and the FDA say.
Food3h
FDA sets ‘achievable’ lead levels for baby food – but are they still too high?
Final guidance from FDA affirms previously proposed caps for lead in packaged baby and toddler food that public health advocates complained did not go far enough – spurring calls for state action.