The Latest Breaking News from Food and Drug Administration

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.

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

The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals, Inc.’s (NASDAQ: REGN) Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH).

A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top vaccine regulator

The Food and Drug Administration (FDA) said on Wednesday it is monitoring a potential safety issue involving Boston Scientific Corporation’s (NYSE:BSX) ENDOTAK RELIANCE defibrillation leads, following a letter from the company alerting healthcare providers of possible reduced shock efficacy.

The Food and Drug Administration has heightened concerns over a nationwide butter recall, escalating the risk level after discovering the presence of an undeclared major allergen.

An unspecified number of cans labeled as Celsius Holdings Inc. (NASDAQ:CELH) energy drinks were accidentally filled with High Noon vodka seltzer before reaching stores, prompting a recall posted to the Food and Drug Administration's website.

In a letter to the U.S. Food and Drug Administration (FDA) Commissioner Marty Makary on Friday, over 80 bipartisan members asked the agency to stop counterfeit and copycat versions of GLP-1 drugs like Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide) and Eli Lilly and Co.’s (NYSE:LLY) Zepbound from flooding the market.

The US Food and Drug Administration (FDA) on Wednesday extended the review period for the Biologics License Application (BLA) for GSK plc’s (NYSE:GSK) Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy.