The FDA has granted a 510 (k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read). The Ibex Prostate ...

GOMEKLI™ is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric ...

Beyond Stargate's big players, a growing number of innovators have been revolutionizing healthcare by making recent ...

Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect, an ...

The FDA granted breakthrough status to Serial CTRS, an AI tool that improves survival predictions in non–small cell lung ...

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance ...

Suzetrigine selectively inhibits the NaV1.8 pain-signaling pathway in the peripheral nervous system and provides effective ...

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

Oxford Drug Design, the Oxford-based AI drug discovery company, has announced further in vivo validation for its first-in-class cancer treatment approach. The company is developing novel treatments ...

US FDA grants fast track designation to Nektar Therapeutics’ rezpegaldesleukin to treat moderate-to-severe atopic dermatitis: San Francisco Tuesday, February 11, 2025, 16:00 Hrs ...