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…
Vertex’s Biologics License Application for Povetacicept Accepted by FDA, Advancing Potential New Treatment for IgA Nephropathy Vertex Pharmaceuticals has reached an important regulatory milestone in its efforts to expand into kidney disease treatment, announcing that the U.S. Food and Drug…
FDA Approves FoundationOne CDx Tests as Companion Diagnostics for TALZENNA and XTANDI in HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer Foundation Medicine, a global precision medicine company dedicated to advancing personalized cancer care, has announced a significant regulatory milestone with the…
Veracyte’s Prosigna Test Shows Practice-Changing Results in Early Breast Cancer at ASCO 2026 OPTIMA Trial Veracyte, Inc., a leading cancer diagnostics company, has announced highly significant results from the independent OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter…
Merck’s Investigational KRAS Inhibitor Calderasib Receives FDA Breakthrough Therapy Designation for First-Line KRAS G12C-Mutated Lung Cancer Merck, known as MSD outside the United States and Canada, has announced a significant regulatory milestone for its oncology pipeline with the U.S. Food…
IMFINZI® (durvalumab) Becomes First Approved Immunotherapy Combination in the U.S. for Patients with BCG-Naïve High-Risk Non-Muscle-Invasive Bladder Cancer AstraZeneca has secured a significant new regulatory milestone for its immunotherapy IMFINZI (durvalumab), with the U.S. Food and Drug Administration (FDA) approving…
ReST Therapeutics Receives FDA IND Clearance for PTSD Therapy RST-101 ReST Therapeutics announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug (IND) application for RST-101, its lead investigational therapy being developed for the early…