FDA to release new guidance soon, clarifying its regulatory framework related to vaccines, particularly COVID-19 shots. Read ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

On May 8, 2025, the U.S. Food and Drug Administration (FDA) extended the public comment period for its proposed rule on front ...

Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday the Food and Drug Administration should change the ...

The FDA currently specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients, according to the agency. Among ...

Merck (MRK) stock in focus as the FDA approves its anticancer agent Welireg for two rare neuroendocrine tumors, expanding its ...

The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's now in question. Dr. Celine Gounder explains what's at stake.

35,180 people played the daily Crossword recently. Can you solve it faster than others?35,180 people played the daily Crossword recently. Can you solve it faster than others?

To help provide meaningful guidance for these and other emerging uses of AI, the FDA is developing regulatory frameworks and policies to ensure AI is used safely and ethically. In January ...

Selection, naming, and labeling of compounded dosage forms containing active moieties that are salt molecules is more complex. Salt (ionic) drugs. The 2013 USP Salt Policy (26) is the basis for FDA ...

"In addition to the established efficacy of CAMZYOS, these meaningful updates to the label reinforce the strong ... allowing them to treat more patients." FDA-approved updates include reduced ...