In response to a study that found heavy metals in infant formulas, the FDA stated it will bolster its testing of infant ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter to Milestone Pharmaceuticals regarding the New Drug Application (NDA) for ...

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, ...

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.

Green Dot Aviation This plane hit WHAT- American 1572 Posted: March 13, 2025 | Last updated: March 13, 2025 On November 12th, 1995, an American Airlines MD-83 carrying 78 passengers and crew is ...

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 ...

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. In many ...

Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the companys aforementioned unit. The company will provide comprehensive response to US ...

This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation," Alembic Pharmaceuticals said in a regulatory filing. The company stated that it will submit a ...

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.

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 ...