Bringing in vitro diagnostic (IVD) products to market in the United States requires more than technological innovation and scientific validation. Manufacturers must navigate an ever-changing ...

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics.

Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site.

CING READ THE FULL CING RESEARCH REPORT Cingulate, Inc. (NASDAQ:CING) reported 2024 results on March 26th, 2025. No revenues ...

There has been considerable interest in a new analysis I published today which makes a bold claim: The FDA's medical product user fee programs are at risk of collapse. You can read the full ...

Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat ...

Pharmacovigilance evolves with technology, employing active surveillance to detect drug-related issues and ensure safety in ...

Enfortumab vedotin with pembrolizumab for untreated unresectable or metastatic urothelial cancer when platinum-based chemotherapy is suitable [ID6332] Draft guidance Technology appraisal guidance 29 ...

Q4 2024 Earnings Conference Call April 9, 2025 8:00 AM ET. Company Participants. Frank Mathias - Chief Executive Officer Sebastien Ribault - Chi ...

These shortcomings often stem from a lack of understanding of appropriate scale development techniques. This article presents a guide to scope, organize, and clarify the process of scale development ...

Q3 2025 Earnings Call Transcript April 3, 2025 Lifecore Biomedical, Inc. misses on earnings expectations. Reported EPS is $-0 ...