fda food and drug administration news

Dupixent, Regeneron and FDA

FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Business Insider · 2h

Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License

MarketWatch · 5h

Regeneron, Sanofi Get New FDA Review of Dupixent for CSU

Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic spontaneous urticaria,

FDA, drug ads

The Associated Press on MSN · 17h

New FDA rules for TV drug ads: Simpler language and no distractions

Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when explaining their medications' risks and side effects.

Newsweek on MSN · 23h

FDA's New Rules Require TV Drug Ads to Be Clearer, More Direct

The new rules become binding on November 20, but many drug companies have already been acting within these requirements. Companies have always been required by the FDA to give a b

Yahoo · 15h

New FDA rules target those ubiquitous TV drug commercials

The agency’s new guidelines are created to eliminate pharmaceutical company practices that minimize or distract consumers from knowing risk information about drugs.

16h

RFK Jr.'s plan for changing the U.S. food and drug system

Robert F. Kennedy Jr., an environmental and anti-vaccine activist, was selected by President-elect Donald Trump to lead the ...

18hon MSN

What Robert F. Kennedy Jr. has said about vaccines, fluoride and food dye as Trump nominates him to head the Department of Health and Human Services

President-elect Donald Trump has named Robert F. Kennedy Jr. as his choice for the next secretary of the Department of Health ...

1monon MSN

FDA issues recalls on at least 16 food and drug items in September. Here's a list

This could be due to U.S. Food and Drug Administration recalls. The FDA has continued to suspend food and drug ...

Agenus Top Brass Sued Over FDA Response to Cancer Drug Trial

Executives and directors of Agenus Inc. misled the public about the results of clinical trials for the biotech’s cancer ...

1monon MSN

FDA approves 1st new drug to treat schizophrenia in more than 30 years

The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with ...

Newsweek19d

Food and Drug Administration

Newsweek magazine delivered to your door Newsweek Voices: Diverse audio opinions Enjoy ad-free browsing on Newsweek.com Comment on articles Newsweek app updates on-the-go ...

Food Safety News7d

FDA updates Food Code for the 50 states

The U.S. Food and Drug Administration has published the 2022 ... The Food Code and the Supplement are joint projects by the FDA, the Centers for Disease Control and Prevention, and the ...

Acsh.org1d

The Media and I: Hurricane Helene and Drug Shortages

Mark Hahn and I discuss the critical vulnerabilities in the U.S. drug supply from Hurricanes Helene and Milton.

Reuters29d

US FDA expands use of Avadel's sleep disorder drug to ages 7 and up

Oct 17 - The U.S. Food and Drug Administration has approved Avadel ... approved for the same condition as Lumryz, Xywav has the FDA's expanded nod to treat idiopathic hypersomnia, a rare ...

Baylor College of Medicine16d

FDA Grants Orphan Drug Designation to Potential Treatment of STXBP1 Developmental and Epileptic Encephalopathy

Research that was carried out by Baylor College of Medicine and Texas Children’s Hospital doctors have led to the U.S. Food ...

Unicycive: FDA to Review Lead Drug Candidate for Hyperphosphatemia

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

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