The Latest Breaking News from Food and Drug Administration

The Food and Drug Administration has cleared the way for the sale of over-the-counter hearing aids, making it possible for consumers to purchase these instruments without medical exams or fittings as soon as this fall. It will likely mean cost savings, but what should those with hearing issues know before…

After a long delay, the Food and Drug Administration issued final regulations Aug. 16, 2022, for over-the-counter hearing aids. The final rule is effective 60 days from its publication, meaning that consumers could see OTC hearing aids hitting the shelves of community pharmacies nationwide by October 2022.

So-called wellness vapes are growing in popularity. Unlike regular vapes (e-cigarettes) that contain nicotine, these products contain vitamins, hormones or essential oils. But they have caught the attention of the US Food and Drug Administration (FDA) because of the unproven health claims made by many of the companies that sell…

Certain batches of Häagen-Dazs ice cream products that have been found to be contaminated with traces of a chemical linked to cancer have not been imported into Thailand, Food and Drug Administration (FDA) deputy secretary-general Weerachai Nolwachai said on Saturday.

The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ:RDUS), New Drug Application (NDA) for elacestrant for patients with ER+/HER2- advanced or metastatic breast cancer. The agency has granted Priority Review designation and assigned a target action date of February 17, 2023. Radius Health…

Plan to multiply 440,000 doses into 2 million is ‘safe and effective’ and will go ahead says HHS secretary

Bristol Myers Squibb (NYSE:BMY) and 2seventy bio (NASDAQ:TSVT) announced positive topline results from KarMMa-3, a Phase 3 study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory. Bristol Myers shares traded in a range of $73.95 to $75.32 on a day volume…

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79 thousand shares, closed regular trading…

The products being recalled range from pre-made coffees to protein shakes and other nutritional beverages. Though no illnesses have been reported, the recalled products should be thrown out.