The Latest Breaking News from FDA

FDA Turns Down a Radiopharmaceutical Cancer Therapy on Manufacturing Grounds, Not on Whether It Works

The FDA rejected a neuroendocrine tumor radiopharmaceutical over manufacturing issues, not efficacy. Here is what that distinction means for patients.

Medical Daily · Aug 12

'You are using sword to kill mosquito': Bombay HC tells Tukaram Mundhe-led FDA to use power judiciously

The Bombay High Court has told the Tukaram Mundhe-led Maharashtra FDA to use its powers judiciously after Cadila Pharmaceuticals challenged a ban on the sale of some medicines. The court questioned the regulator’s approach and accepted its assurance to revoke the orders, issue show-cause notices and hear the company before…

The Economic Times · Aug 12

FDA Proposes Requiring Companies to Report Food Additives That Now Reach Grocery Shelves Without Federal Review

FDA has released its proposed GRAS rule requiring companies to notify the agency about food additives. Here is what the proposal does and does not do.

Medical Daily · Aug 12

Popular Schwarzkopf Hair Mousse Recalled Nationwide Over Risk Cans Could Explode

Henkel Corp. is voluntarily recalling its Schwarzkopf Professional Osis Grip Extra Strong Mousse in the 6.76 fl. oz/200 ml size due to a packaging defect that could cause the product to leak under pressure, creating a risk of explosion, according to an official announcement posted by the U.S. Food and…

Grocery Coupon Guide · Aug 11

The Obesity Drug Race Moves Past Ozempic with a Shot Targeting Three Hormones

Eli Lilly's retatrutide produced up to 30.3% average weight loss in phase 3 trials. Approval is not expected before 2027 at the earliest.

Medical Daily · Aug 11

FDA cleared a huge Samsung Galaxy Buds feature to help you hear every moment

The FDA approved a huge Samsung Galaxy Buds feature to help users monitor and understand their hearing health.

Android Central · Aug 11

Bombay HC warns Maharashtra FDA for ‘sword to kill mosquito’ approach as Cadila challenges drug ban

The Bombay High Court criticized the Maharashtra FDA for its drastic actions against companies. The court directed the regulator to grant hearings before taking severe measures. This directive came after Cadila Pharmaceuticals challenged the FDA's drug seizure and sales ban. The FDA agreed to revoke orders and provide hearings to…

The Economic Times · Aug 11

RFK Jr. Wants More FDA Oversight of Food Ingredients. It Could End Up Costing $210 Million.

A proposed FDA rule would require food manufacturers to disclose ingredients they deem safe, which the agency admits would have a “significant economic impact” on small businesses.

Reason · Aug 11

Peptides Labeled for Research Only Are Not Approved Medicines and People Are Injecting Them Anyway

Peptides sold online as research use only get no purity or sterility verification before sale, and FDA reviewers found the human evidence thin.

Medical Daily · Aug 11

Targeted Radiation Drugs Were Built to Spare Healthy Tissue and Trials Are Showing a More Complicated Picture

Radiopharmaceuticals deliver radiation directly to tumors, but developers report isotopes reaching the kidneys, liver, and bone marrow in clinical trials.

Medical Daily · Aug 11