Sarepta Therapeutics, FDA and gene
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The Food and Drug Administration (FDA) has been busy lately with various recalls. One involved Power Stick deodorant and another involved various ice cream bars across 23 states. Now, a new recall was announced on Monday by the FDA,
Replimune (NASDAQ:REPL) announced on Tuesday that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding its marketing application for its lead asset, RP1, declining to approve it as part of a combination regimen for melanoma,
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy Kits containing recalled Codman Disposable Perforators 14mm due to the potential of serious injury or death.
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Health and Me on MSN"Obsolete And Unnecessary": FDA Set To Revoke 52 Nutrition And Labeling RulesThe FDA plans to revoke 52 outdated nutrition and labeling regulations to streamline food industry standards, citing them as obsolete and no longer necessary for modern practices.
The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary or medically reversible adverse health consequences." However, the classification is also used "where the probability of serious adverse health consequences is remote."
WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.
US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels on Hormone Replacement Therapy.