FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil
May 14, 2025 22:57 ET | Source: Mesoblast Limited NEW YORK, May…
Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
April 29, 2025 01:00 ET | Source: F. Hoffmann-La Roche Ltd The…
KOLON TISSUEGENE HIGHLIGHTS LONG-TERM SAFETY DATA AND POTENTIAL U.S. FDA PATHWAY FOR TG-C AT OARSI WORLD CONGRESS
THE WORLD'S MOST PRESTIGIOUS OSTEOARTHRITIS SOCIETY (OARSI) HELD FOR THE FIRST TIME…
BlackfinBio Announces FDA Clearance to Initiate Phase 1/2 Clinical Trial for Novel AAV Gene Therapy BFB-101 to Treat the Rare Neurological Disease Hereditary Spastic Paraplegia, Type 47 (SPG47)
April 28, 2025 04:00 ET | Source: BlackfinBio CHESHIRE, United Kingdom, April…
U.S. FDA clears first stapler designed for single-port robotic surgery
Intuitive’s SureForm 45 stapler available for thoracic, colorectal, and urology procedures April…
DOSIsoft PLANET Onco Dose receives CE MDR Mark and new FDA 510(k) clearance
PARIS, April 7, 2025 /PRNewswire/ -- DOSIsoft, leading provider of patient-specific imaging and…
FDA Watch: The Quiet Gold Rush in AI-Powered Medical Devices
Equity Insider News Commentary Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, April…
FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer
Ad hoc announcement pursuant to Art. 53 LR New indication approximately triples…
Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia
NIJMEGEN, The Netherlands, March 26, 2025 (GLOBE NEWSWIRE) -- Pleco Therapeutics, a…
FDA Issues Nyxoah an Approvable Letter for its Genio System
INSIDE INFORMATIONREGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio®…