Apyx Medical Corporation Submits 510(k) Premarket Notification to the U.S. Food and Drug Administration for the AYON Body Contouring System™
Focusing on advancing body contouring by providing the first all-in-one platform for the surgical suiteCLEARWATER, Fla., Jan.
Lay's potato chips, cucumbers, puppy food and more FDA recalls in December 2024
Most of the recalls are contamination or allergen-based. While 2025 is near, there are still callbacks to be aware of. Here ...
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.
STAT4d
Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
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, 2025 Cyprium is eligible to receive ...
BioPharma Dive2h
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
News Medical on MSN2h
Inogen receives FDA 510(k) clearance for SIMEOX 200 airway clearance device
Inogen, Inc., a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) ...
Rolling Out17h
The FDA’s shocking findings from tampon investigation
The FDA’s investigation into tampons has uncovered startling details. What could this mean for feminine hygiene products?
Pharmaceutical Technology40m
FDA grants ODD to NMD Pharma’s Charcot-Marie-Tooth disease therapy
The US FDA has granted ODD to NMD Pharma’s oral lead development programme, NMD670, designed to treat Charcot-Marie-Tooth disease (CMT).
Food Safety News10h
FDA warns Stew Leonard’s Holdings over misbranded cookie products following anaphylactic death
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
FDA approves new drug for advanced Parkinson’s Disease
Thousands of Americans are diagnosed every year with Parkinson’s Disease. It’s a movement disorder that affects the central ...
Cure Today1d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...