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COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
US FDA approves J&J's immune disorder drug
The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...
Exclusive: Trump administration banned chosen names at FDA, CDC, NIH under new gender policy
Health and Human Services employees were told in March to remove 'nicknames' from email systems and signatures to comply with ...
Bread Recalled Over 'Glass Fragments' as FDA Warns Consumption Could Cause 'Adverse Health Consequences'
Bread and rolls sold in six states have been recalled over 'glass fragments,' according to the U.S. Food and Drug ...
FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
MedPage Today5h
FDA Approves Nipocalimab for Adult and Pediatric Myasthenia Gravis
The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia ...
STAT13h
Will the FDA approve the first new drug to help people quit smoking in 20 years?
The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...
BioPharma Dive4h
J&J secures FDA OK for immune drug touted as future blockbuster
The company has predicted that Imaavy — now approved for generalized myasthenia gravis — could eventually earn more than $5 ...
FDA issues urgent nationwide recall of bread sold in US found with 'glass fragments'
An urgent recall for hundreds of cases of frozen bread sold throughout the U.S. was issued after the FDA said "glass ...
FDA chief says they're looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.