Scientific American

Health Experts Slam Possible FDA “Black Box” Warning for COVID Vaccines

The FDA is reportedly weighing adding high-level warning labels to COVID vaccines, a move that some experts say may cause ...
Healio

Q&A: How to ‘improve’ an FDA label with evidence, advocacy

Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...

FDA intends to put its most serious warning on Covid vaccines, sources say

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.
Pulmonology Advisor

Dozens of Counterfeit Ozempic Seized by the FDA

Dozens of units of counterfeit Ozempic (semaglutide 1mg injection) were seized by the FDA, according to a drug safety alert issued by the Agency.
pharmaphorum

Sarepta rises after FDA adds warning label to Elevidys

Shares in Sarepta reversed some of their recent declines after the FDA added a warning label to its Duchenne muscular dystrophy (DMD) gene therapy, ending a protracted period of uncertainty for the ...
STAT

Pharmalittle: We’re reading about FDA plans for CAR-T therapies, skinny drug labels, and much more

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...

FDA panel calls to loosen restrictions on testosterone replacement therapy

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.
Food Engineering

FDA Could Finalize Front-of-Pack Nutrition Label Rule in Spring 2026

The agency’s proposed rule would require the display of a compact informational box containing certain nutrient information.
Philippine News Agency

FDA warns shoppers: Check toy labels for safer holiday gifts

As families prepare for the holiday season, the Food and Drug Administration (FDA) on Friday urged consumers to carefully ...
Medical Marketing & Media

Two new Untitled Letters, multiple close-outs: Latest on FDA’s pharma ad crackdown

More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one backdated for November 24 for Daiichi Sankyo’s tenosynovial giant cell ...
The Business Journals

Sarepta Duchenne gene therapy gets strongest FDA label after patient deaths

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the ...
The Business Journals

Gene therapy invented at Children's gets strongest FDA label after patient deaths

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...