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The Latest Breaking News from Food and Drug Administration

US drug regulator issues import alert for drugs made at a Dabur India plant

The US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed significant issues with data integrity and factory maintenance. Critical manufacturing records were reportedly falsified. Live birds and droppings were also found in a raw material warehouse.

The Economic Times

FDA staff blindsided by org’s about-face on flavored vapes, contradicting MAHA goals

The vaping guidelines bypassed a federally mandated period for public comment and revisions

The Independent UK

Cassidy’s defeat complicates Senate Health committee’s future

Sen. Bill Cassidy’s loss in the Louisiana Republican primary over the weekend puts the future of the powerful Health, Education, Labor and Pensions Committee in flux. During his tenure as HELP chair, Cassidy has pushed legislative priorities such as a proposal to establish pre-funded health savings accounts for people on…

Roll Call

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Flavored vapes led to a major shake-up at the FDA – 3 health policy analysts explain the science behind the controversial products

The resignation of Marty Makary, commissioner of the U.S. Food and Drug Administration, on May 12, 2026, brought to the forefront a heated controversy over fruit-flavored nicotine vapes.

The Conversation

FDA official who scrutinized COVID shots and antidepressants is out in latest shake-up

The Food and Drug Administration's top drug official is stepping down in the latest shake-up at the powerful health agency

The Independent UK

FDA turmoil deepens as top drug chief departs claiming she was fired

Dr Tracy Beth Høeg, the Food and Drug Administration’s top drug regulator, says she was fired from agency after declining to resign

The Guardian - US

Makary out at FDA after facing pressure to resign

Food and Drug Administration Commissioner Marty Makary will leave his role, President Donald Trump said Tuesday. Makary’s departure comes after pressure within the administration to step down over a variety of issues, from abortion medication to flavored vapes. FDA Deputy Commissioner for Food Kyle Diamantas will lead the agency in an acting capacity. He…

Roll Call

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Report: FDA Commissioner Set To Be Fired, Sources Say Trump Could Still Change His Mind

Makary is scheduled to testify before the Senate Appropriations Committee on May 13 on the FDA's budget for the coming fiscal year. He was appointed to his post last year.

Latin Times

What to know about the federal rule that Texans have used to mail in abortion pills

In 2023, the Food and Drug Administration started allowing mifepristone to be delivered by mail. The federal courts are deciding whether to pull that permission.

The Texas Tribune

FDA finds US infant formula supply is ‘safe’ after examining 300 samples in Operation Stork Speed

The review was conducted as part of the Food and Drug Administration’s Operation Stork Speed project

The Independent UK

Trump Signs Executive Order Endorsing Psychedelic Psilocybin and Ibogaine; Asks 'Can I Have Some, Please?'

President Trump signed an executive order to expedite the review and funding of psychedelic drugs such as psilocybin and ibogaine to treat serious mental illnesses and address public health crises.

International Business Times UK

Discount supermarket Lidl pulls festive chocolates from US shelves in urgent recall

Favorina Chocolate Ladybugs, a popular German-Style Nougat, contain hazelnuts – posing a potentially life-threatening risk

The Independent UK

FDA proposes new system for approving customized drugs and therapies for rare diseases

The Food and Drug Administration is proposing a system for approving customized drugs and medical treatments for patients with rare or hard-to-treat diseases

The Independent UK

FDA’s abrupt flip-flop on Moderna’s mRNA flu shot highlights growing risks to drug-makers of investing in vaccines

The Food and Drug Administration’s decision, made public on Feb. 10, 2026, to not review an application to approve Moderna’s proposed mRNA-based flu vaccine set off a firestorm of criticism from public health experts.

The Conversation

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The Conversation

FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine.

The Independent UK

House lawmaker raises new concerns over FDA's ultra-fast drug review program

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs

Times Life

7 Things That Will Get Cheaper After Budget 2026

Most budgets promise relief. Very few actually change what you pay in real life. Budget 2026 is one of those rare ones that works quietly. There were no dramatic tax cuts, no loud announcements, and no instant price drops flashed across screens. Yet, beneath the fine print, the government made…

The Independent UK

Legal questions swirl around FDA's new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been rocked by recent layoffs and resignations

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The Independent UK

A 74 year-old woman distributed 150,000 doses of fentanyl in the mail in ‘side hustle’ to pay for her meds

The elderly woman sent more than 1,000 parcels suspected to have contained illegal drugs, with a raid on her Austin home uncovering 18,000 pills

The Conversation

FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access

The Food and Drug Administration is seeking to drastically change procedures for testing vaccine safety and approving vaccines, based on unproven claims that mRNA-based COVID-19 vaccines caused the death of at least 10 children.

The Guardian - US

FDA drug chief signals possible exit as agency turmoil deepens

Richard Pazdur’s potential retirement weeks into the role adds to upheaval at the FDA amid political pressure

Benzinga

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

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

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

FDA Adds New Warning For Johnson & Johnson's Cancer Cell Therapy

The Food and Drug Administration (FDA) has updated safety labeling for Johnson Johnson's (NYSE:JNJ) Carvykti after receiving reports of immune effector cell-associated enterocolitis (IEC-EC)—a rare but serious complication seen in both clinical trials and postmarketing data.

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