Regeneron’s RNA Med for Muscle Disease Meets Trial Goals; FDA Filing Planned for Next Year
A Regeneron Pharmaceuticals drug that lowers levels of a disease-driving protein has met the goals of a pivotal test in ...
Tag: FDA
FDA to publish daily reports of adverse events tied to drugs
WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs ...
FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns
The US Food and Drug Administration (FDA) is warning consumers to avoid sunscreens sold in whipped, mousse, or foam forms, ...
Pfizer Covid vaccine for young children may not be renewed by FDA | US news
Pfizer’s Covid vaccine for young children may not be renewed by the US Food and Drug Administration (FDA) this fall, ...
FDA to stress opioids’ risk of overdose, death in new medication safety labels
The Food and Drug Administration will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning ...
Ouster of Vinay Prasad, top FDA official
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and ...
Two easy ways for the FDA to improve transparency
The U.S. Food and Drug Administration was slammed recently for overhyping its disclosure of a set of rejection notices it ...
New CDER director at FDA, how rescissions affect health policy
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign ...
Conservative politicians using flawed abortion-pill report to attack FDA
For decades, the Food and Drug Administration has partnered with clinicians and industry to deliver evidence-based medical innovations using a ...
FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease
Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy has come up short at the FDA, with the regulator rejecting the ...
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