A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

Shea, one of 1,310 people who responded to a poll the health policy research group KFF conducted on health care priorities, said he assumes the FDA is making sure the ingredients are safe.

CRL focused on CMC; no clinical issues relating to etripamil raised$69.7M in cash, cash equivalents and short-term investments as of December 31, ...

Kennedy Jr., another crucial governmental health leadership nominee—the proposed head of the FDA—took center stage Thursday. At his confirmation hearing before the Senate’s Health ...

March 4, 2025 -- The FDA has approved the first new clot-busting drug in nearly 30 years, offering a faster way to dissolve blood clots in adults who suffer a stroke. The treatment ...

A key lab that oversees US pharmaceutical safety is in limbo following moves by the Department of Government Efficiency, raising questions about the fate of the lab and the new administration’s ...

The FDA's Substances Generally Recognized as Safe -- or GRAS -- rule will be revised to enhance the agency's oversight of ingredients and provide transparency for American consumers. HHS also ...

Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug ... (subcutaneous use), a new pharmaceutical form (solution for injection) and a new ...