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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 Dive17m
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 ...
medtechdive56m
FDA aims to stem AI device bias, boost transparency in draft guidance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 ...
JD Supra1h
MoCRA Guidance Update for Registration and Listing of Cosmetic Product Facilities and Products
What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of ...
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 ...
IFLScience1h
Decades-Old Problem Of Pulse Oximetry Across Skin Tones Targeted By New Draft FDA Guidance
Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...
Withings’ blood pressure monitor comes with your own cardiologist inside
Withings' BPM Vision blood pressure monitor has a color screen, different cuff sizes, and the option to have a cardiologist ...
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FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...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 ...