The Latest Breaking News from FDA

AI EKG Tool Authorized by FDA Aims to Flag Heart Attacks That Standard ST-Elevation Criteria Can Miss

The FDA granted de novo authorization to Queen of Hearts, an AI EKG model for heart attack triage. What the evidence shows and what patients should know.

Medical Daily · Sep 16

IV Start Kit Recall Gets FDA's Most Serious Class I Rating Over Fungus in Skin Prep Applicators

FDA classified an AVID Medical IV start kit recall as Class I due to fungal contamination in BD ChloraPrep applicators. No injuries have been reported.

Medical Daily · Sep 16

Some Pancreatic Cancer Families Hit Insurance Delays After Rasonque Approval Closed the Drug's Free Early Access Program

FDA approval of the pancreatic cancer pill Rasonque closed its free early access program before some insurers were ready to cover it.

Medical Daily · Sep 16

Tukaram Mundhe strikes again: FDA shuts Mumbai's iconic Cafe Mondegar in statewide raid over hygiene breaches

Maharashtra FDA suspended licenses of four food businesses for hygiene breaches. Officials inspected thirty-eight establishments and collected forty-seven food samples statewide. Dairy product seizures occurred across multiple districts due to quality and labelling issues. Joint operations also intercepted significant quantities of banned gutkha products.

The Economic Times · Sep 15

FDA Cuts Monitoring After Imdelltra's First Two Doses to Six to Eight Hours for Small Cell Lung Cancer

FDA cut monitoring after Imdelltra's first two doses from 22 to 24 hours to 6 to 8 hours, which may bring treatment closer to home for some patients.

Medical Daily · Sep 15

New Telehealth Company Offers Off-Label GLP-1 Treatment for Addiction in 41 States as Key Trials Remain Unfinished

Quel Health says clinicians on its platform may prescribe GLP-1 drugs off-label for addiction in 41 states. What the FDA has and has not approved.

Medical Daily · Sep 15

Federal Lawsuit Seeks to Bar Minneapolis Distributor from Handling Food and Medicines After Inspectors Found Rodents

The Justice Department wants a court to bar Gold Star Distribution from handling FDA-regulated goods after inspectors found rodents, birds, and droppings.

Medical Daily · Sep 15

Ameluz Red-Light Therapy Wins FDA Approval for Superficial Basal Cell Carcinoma After Clearing 66% of Main Tumors

FDA-approved Ameluz gel with red-light therapy for superficial basal cell carcinoma. See the trial results, who may qualify, and what remains unknown.

Medical Daily · Sep 15

Adults with Rare Pancreatic and Digestive Tract Tumors Gain Bexlutry, a Second FDA-Approved Version of Targeted Radiation Therapy

The FDA approved Bexlutry, a second lutetium Lu 177 dotatate product for adults with GEP-NETs. Who qualifies, the data, and key side effects.

Medical Daily · Sep 15

Whole Foods Recalls Cabricharme Cheese from 18 Stores in Seven States Because It Contains an Unlisted Egg Protein

Whole Foods recalled Cabricharme cheese from 18 stores in 7 states due to undeclared egg lysozyme. How to check PLU codes and best-by dates at home.

Medical Daily · Sep 15