Sonoma, CA — Primavera Nueva Inc. is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes, an organism which
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List of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.Products Containing 7-OH Can Cause Serious Harm
The FDA recommends that consumers avoid 7-OH products, including foods, dietary supplements and those claiming to treat an ailment or disorder. 7-OH is not approved as a drug by the FDA.FDA’s ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
FDA’s Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first proFDA approves new treatment for acromegaly, a rare endocrine disorder
The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization processDrug Trials Snapshots: HERNEXEOS
Drug Trials Snapshots: HERNEXEOS
