This includes products such as the WATCHMAN FLX LAAC device ... after the U.S. Food and Drug Administration (FDA) authorized the marketing of all ZYN nicotine pouch products currently sold ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

The FDA has slapped Empower Pharma with a warning letter citing a laundry list of production issues that put the company in violation of its 503B compounding credentials under the Federal Food ...

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio ...

In January, the FDA released a warning letter about a new canine allergy drug called Zenrelia. The letter updated safety ...

The FDA has asked the commissioner’s office to set a hearing by mid-September 2025 for Vanda's request, which was prompted by a complete response letter (CRL). In a letter to the biotech last ...

The FDA told the drugmaker in a letter that its drug submitted to treat dry eye disease has not proven its effectiveness in enough trials. The company said it expects to release data from an ...

But in an interesting twist, Mr. Haider now alleges that Clarence Massaquoi, C&C Corporation's CEO, forged the bargaining letter from which the FDA approved the company's operations in the ...

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® ...

the FDA letter says. "Your firm should take prompt action to address the violations identified in this letter," the agency said. "Failure to adequately address this matter may result in regulatory ...

Kennedy Jr.'s layoffs. Kennedy initially planned to cut 3,500 employees from the FDA. In team-wide meetings that started last week, multiple FDA employees said they were informed by their ...

has officially received the "No Questions" letter from the U.S. Food and Drug Administration (FDA) regarding its GRAS (Generally Recognized as Safe) status. The GRAS designation recognizes it as ...