FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
drugdeliverybusiness4h
Fractyl Health announces layoffs as it pivots to gene therapy
Fractyl Health (Nasdaq:GUTS) is cutting nearly a fifth of its workforce as it streamlines resources and shifts focus toward ...
bernama15h
Modella AI’s PathChat Obtains FDA Breakthrough Device Designation For Advancing Pathology Diagnostic
KUALA LUMPUR, Feb 3 (Bernama) -- Modella AI, a pioneer in generative and agentic artificial intelligence (AI) for biomedicine ...
clinicaladvisor.com3d
Brelovitug Granted Breakthrough Designation for Chronic Hepatitis Delta
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).
What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of ...
Vertex gets FDA approval for non-opioid pain reliever
Shares of Vertex Pharmaceuticals (NASDAQ:VRTX) rose 3% in post-market trading Thursday on news the company had received FDA ...
JD Supra4d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
Pharmabiz5d
Beckman Coulter receives US FDA breakthrough device designation for Alzheimer’s disease blood test
Beckman Coulter receives US FDA breakthrough device designation for Alzheimer’s disease blood test: Brea, California Wednesday, January 29, 2025, 16:00 Hrs [IST] Beckman Coulter ...
manilatimes5d
ONWARD Medical's ARC-EX System Now Available on US Veterans Affairs Online Procurement Platforms
ONWARD ARC-EX System for spinal cord injury is now available for purchase through VA Federal Supply Schedule and GSA ...
Modella AI’s Generative AI Co-Pilot PathChat Receives FDA Breakthrough Device Designation
Modella AI, a pioneer in generative and agentic artificial intelligence for biomedicine, is proud to announce that its ...
TMCnet6d
Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study
Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for use of the DeepView™ System and expects to submit ...