Sarepta Therapeutics, FDA and gene
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The first recall affects tuna salad and ready-to-eat foods containing tuna salad sold at Jewel-Osco (which is owned by Albertsons) stores in three states: Illinois, Indiana, and Iowa. The second recall affects tuna salad and ready-to-eat foods containing tuna salad sold at three other stores in the Albertsons family,
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 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."
Thursday’s authorization, following a multiyear FDA review, has come under scrutiny, including from Yolanda Richardson, president and CEO of Campaign for Tobacco-Free Kids, who called it a “big step” backward for preventing youth e-cigarette use.
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Health and Me on MSN"Obsolete And Unnecessary": FDA Set To Revoke 52 Nutrition And Labeling Rules
The FDA plans to revoke 52 outdated nutrition and labeling regulations to streamline food industry standards, citing them as obsolete and no longer necessary for modern practices.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 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.
US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels on Hormone Replacement Therapy.
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may