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FDA's Prasad Cites Alleged Child COVID Shot Deaths in Push for Stricter Rules

The Food and Drug Administration’s top vaccine regulator is pushing new limits on how vaccines win approval. The tougher standards could cloud prospects for vaccine makers and rattle investors in major healthcare and biotech names.

Benzinga · Nov 29, 2025

The FDA’s Understated Concern About Unsecured Healthcare Software

The Food and Drug Administration has long been associated with drug approvals and food safety, but its role in regulating medical technology is just as...

Saving Advice · Nov 29, 2025

Why Heartbeam Shares Are Trading Higher By Around 43%; Here Are 20 Stocks Moving Premarket

Shares of Heartbeam Inc (NASDAQ:BEAT) rose sharply in pre-market trading after announcing its regulatory strategy following the Food and Drug Administration’s Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.

Benzinga · Nov 28, 2025

FDA recall of blood pressure pills due to cancer-causing contaminant may point to higher safety risks in older generic drugs

A generic blood pressure drug called prazosin, made by Teva Pharmaceuticals, is being recalled by the Food and Drug Administration because it contains elevated levels of cancer-causing chemicals called nitrosamines.

The Conversation · Nov 7, 2025

FDA Drug Chief George Tidmarsh Resigns After Allegations Of Power Misuse

George Tidmarsh, head of the Food and Drug Administration’s (FDA) drug center, resigned Sunday following allegations that he misused his regulatory power to financially harm a former business associate.

Benzinga · Nov 3, 2025

FDA health warning as restriction placed on kids’ fluoride supplements

The agency sent a form letter to dentists and other health providers warning about the risks of the products

The Independent UK · Oct 31, 2025

DexCom Faces New Reports Of Deaths Linked To G7 Glucose Monitor

DexCom Inc (NASDAQ:DXCM) is facing renewed scrutiny after three people with diabetes reportedly died following issues with its G7 continuous glucose monitor, according to adverse event filings submitted to the Food and Drug Administration in September.

Benzinga · Oct 28, 2025

7 FDA Approvals That Should Never Have Happened

Every time you see the words “FDA approved,” it’s supposed to mean safety, science, and trust. After all, the Food and Drug Administration is the final checkpoint before a product reaches your medicine cabinet, right? But history says otherwise. Over the years, some truly shocking—and sometimes disastrous—products have slipped through…

Everybody Loves Your Money · Oct 24, 2025

Tylenol-Maker Kenvue’s Stock Is Down 30% in 2025. Its Fate May Be in the FDA’s Hands.

The former consumer health unit of Johnson & Johnson remains mired in troubles surrounding Tylenol.

Barchart · Oct 22, 2025

FDA Unveils First Experimental Drugs Under Fast-Track Voucher Plan To Cut Drug Review Times

The Food and Drug Administration announced on Thursday the first round of experimental drugs to be included in a priority voucher program. This FDA initiative is designed to expedite drug review processes for products that align with critical U.S. national health priorities, reducing review times from 10 to 12 months…

Benzinga · Oct 17, 2025