The Food and Drug Administration OK'd 10 Zyn flavors, including coffee, mint and menthol. It's the first time regulators have authorized sales of nicotine pouches, which are the fastest-growing ...

The tentative approval for ANDA 218862 was posted to the Drugs@FDA site. Discover outperforming stocks and invest smarter with Top Smart Score Stocks Filter, analyze, and streamline your search ...

Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter. The biotechnology company said the ...

SILVER SPRING, Md., Jan. 16, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product ...

SILVER SPRING, Md., Jan. 16, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product ...

The draft guidance highlights FDA’s continued focus on transparency, AI bias, data quality, human factors, change management, and cybersecurity as important criteria for premarket submissions ...

The United States Food and Drug Administration (FDA) has banned Red Dye No. 3, citing concerns over the ingredient as a significant cancer risk. The ban will take effect in January 2027 or 2028 ...

Incyte (INCY) and Syndax (SNDX) announced that the FDA has approved Niktimvo in 9 mg and 22 mg vial sizes. The companies expect product to be available for order in the U.S. in early February.

The proposed rule from the Food and Drug Administration comes in the final days of President Joe Biden’s term, greatly reducing the likelihood that it will actually be enacted. President-elect ...

WASHINGTON — The Food and Drug Administration proposed new rules Tuesday that would require most packaged foods to display simplified nutrition information on the front of packages in addition ...