FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.

An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...

Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...

More than 35 million Americans have to deal with compacted earwax, according to studies by SafKan Health. This medical device ...

UW Medicine is unveiling an FDA-approved spinal cord therapy in an effort to offer new hope for paralyzed patients.

Ozempic is already widely used and was first FDA-approved ... development, medical & regulatory affairs for Novo Nordisk, maker of Ozempic — in a press release. “This approval for Ozempic ...

Shares of Innovate rose after the Food and Drug Administration approved the company's device to assess kidney function. The stock was 43% higher, at $7.30, midday Tuesday, the first day of trading ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

The FDA is ramping up efforts to address medical device shortages that are increasingly threatening patient care, particularly for pediatric and neonatal populations. In a Jan. 16 news release ...

"JenaValve Trilogy System’s FDA approval to expand indications to aortic regurgitation" was originally created and published by Medical Device Network, a GlobalData owned brand.

Thai FDA warns against using unapproved smart devices for blood sugar monitoring due to health risks and lack of scientific ...