Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
aha.org20m
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
Soap Central Lifestyle on MSN9h
Why did FDA issue a recall over Cheese Puffs? Drama explained
Monosodium glutamate, or MSG, was one of the unreported flavor enhancers; according to the FDA, it is "generally recognized ...
Cheese Puffs Recall as FDA Issues Risk Warning
The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
Baby Milk Recall Over Foreign Material Contamination Fears
A total of 136 bottles of pasteurized human milk were recalled by the Minnesota Milk Bank For Babies in December, according to the Food and Drug Administration.
Cure Today3d
FDA Reviews NDA for Dordaviprone in Recurrent H3 K27M-Mutant Diffuse Glioma
Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...
Costco egg recall: These eggs with a risk of salmonella could still be in your refrigerator
Costco eggs recalled were given a recall of the highest level by the Food and Drug Administration for potential contamination with salmonella.
Becker's Hospital Review4d
Most influential drug approvals of 2024: GoodRx
Discover the top 19 most notable drugs approved by the FDA in 2024, including Dupixent for COPD and FluMist for self-administration. See the full list here.
thehealthy5d
FDA Announcement: The First Generic GLP-1 Shot Has Just Been Approved
This may start to bring down the cost of brand-name competitors—here's who might get access, and one major difference from ...
Drug Store News5d
Hikma gets FDA nod for generic Victoza, launches 2 new generics
Generic Victoza is a GLP-1 receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 ...
19 drug approvals in 2024 that had 'big clinical impact,' according to GoodRx
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of ...