Incyte Japan Secures Approval for Minjuvi Combo in Relapsed or Refractory DLBCL Incyte Biosciences Japan G.K. has secured a significant regulatory milestone in Japan with the approval of Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adult patients…
AngioDynamics Receives FDA Approval to Launch RELIEF Study Evaluating NanoKnife Technology for Benign Prostatic Hyperplasia AngioDynamics, Inc., a medical technology company focused on advancing innovative therapies that improve vascular health, expand cancer treatment options, and enhance patient quality of life,…
Guided Therapeutics Submits Positive LuViva Clinical Trial Results to FDA, Demonstrating Enhanced Detection of Precancerous Cervical Disease Guided Therapeutics, Inc., a medical technology company focused on improving cervical cancer detection and prevention, has announced the submission of results from its…
Arialys Therapeutics Advances ART5803 Development With Phase 2 Progress and FDA Clearance for New Clinical Study in Anti-NMDA Receptor Encephalitis Arialys Therapeutics, a clinical-stage biotechnology company focused on developing precision medicines for autoimmune neuropsychiatric disorders, has announced significant clinical and…
Genentech’s Tecentriq Moves Closer to Potential New Standard of Care in Early Colon Cancer Following FDA Priority Review Acceptance Genentech, a member of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental…
KARL STORZ Receives FDA Clearance for Rubina™ Lens Exoscope, Expanding Near-Infrared Imaging Capabilities in Open Surgery KARL STORZ, a global leader in endoscopic and minimally invasive surgical technologies, has announced that the U.S. Food and Drug Administration (FDA) has granted…
Multi Radiance Medical Secures Expanded FDA Clearance for Lateral Epicondylitis Following Successful Triple-Blind Clinical Trial Multi Radiance Medical, a global leader in Super Pulsed Laser technology and photobiomodulation research, has announced that the U.S. Food and Drug Administration has granted…
Biogen’s Salanersen Granted FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy Biogen Inc. (Nasdaq: BIIB) has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to salanersen, an investigational antisense oligonucleotide (ASO) being developed for…
Verastem Oncology’s VS-7375 Receives FDA Fast Track Designation for KRAS G12D-Mutated Non-Small Cell Lung Cancer Verastem Oncology, a biopharmaceutical company focused on developing targeted therapies for cancers driven by the RAS/MAPK signaling pathway, has announced that the U.S. Food and…
QT Imaging Secures Saudi FDA Approval for Breast Acoustic CT Scanner, Advancing Expansion Across Gulf Healthcare Market QT Imaging Holdings, Inc., a medical device company focused on transforming breast health management through advanced radiation-free imaging technology, has announced that its…
Terremoto Biosciences Receives FDA Fast Track Designation for TER-2013 in Advanced HR+/HER2- Breast Cancer Terremoto Biosciences, a biotechnology company focused on developing highly targeted small-molecule therapies for cancer, has announced that the U.S. Food and Drug Administration (FDA) has granted…
Shionogi’s XOCOVA® Becomes First FDA-Approved Oral Treatment for Preventing COVID-19 Following Exposure Shionogi & Co., Ltd. has announced a significant regulatory milestone for its antiviral medicine XOCOVA® (ensitrelvir), with the U.S. Food and Drug Administration (FDA) granting approval for the…