The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
director of the FDA’s Center for Tobacco Products, said in the release. “The $76 million these bad actors just put in the dumpster should be a sobering reminder that their time and money would ...
ClearPoint Neuro (CLPT) “announced the U.S. Food and Drug Administration has granted marketing authorization for the SmartFlow Neuro ...
Trump ally Robert F. Kennedy Jr. has expressed skepticism about vaccines and vowed to restructure federal health agencies.
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
PTC Therapeutics (PTCT) announced that the FDA accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever ...
The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications. The agency said an extensive ...
Its far easier to get a new nicotine pouch (such as Zyn) through the FDA’s Center for Tobacco Products than it is to get a cessation therapy through the regulator’s Center for Drug Evaluation ...
The investigation is in its early stages, and 33 patients have been discovered. The Food and Drug Administration has not released any patient information, such as where the patients live or their ...
LONDON — AstraZeneca said Tuesday it has had to resubmit a closely watched medicine for U.S. approval in a different form of ...
The survey found that 2.25 million teens reported using a tobacco product in the past 30 days, compared with 2.8 million in 2023.
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