FDA Will Ask Sarepta to Halt Gene Therapy Shipments
Digest more
FDA approves JUUL vapes
Digest more
"I may have been swayed if this represented a major advance in the field," said panelist Walter Dunn, MD, PhD, of the University of California Los Angeles and the West Los Angeles VA Medical Center. "At best I think it's potentially incremental."
Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes.
Explore more
(Reuters) -The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's drug when used in combination with Viatris' Zoloft for the treatment of adults with PTSD.
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even after banning the factory from the U.S. market because of quality problems.
The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering evergreen, for use in a variety of drinks and candies.
The Food and Drug Administration is reassessing some warnings given about hormone therapy treatments for menopause that have led to some women avoiding the option, even if it could help them.
17hon MSN
Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a salmonella outbreak.
The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other foods. The FDA has reviewed its portfolio of more than 250 food Standards of Identity to "make sure they are useful, relevant, and serve consumers in the best possible way."