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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 Dive40m
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 ...
scrippsnews42m
FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
KERA News1h
With lawsuits and legislation, Texas Republicans take aim at abortion pills
More than 2,800 Texans are getting abortion pills through the mail from out-of-state every month, prompting a lawsuit and ...
medtechdive1h
FDA aims to stem AI device bias, boost transparency in draft guidance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 ...
healthday1h
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon ge ...
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 Supra3h
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...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.