Pfizer’s IBRANCE Wins FDA Approval in HR+/HER2+ Metastatic Breast Cancer, Expanding CDK4/6 Use Into New Maintenance Setting Pfizer has secured a significant new U.S. regulatory milestone for IBRANCE (palbociclib), with the U.S. Food and Drug Administration approving the CDK4/6 inhibitor…
EMD Serono Names Miguel Fernández Alcalde Head of Global Commercial Strategy, Appoints Monia Vial to Lead North America EMD Serono, the Healthcare business of Merck KGaA in the United States and Canada, has announced a significant leadership transition that reshapes…
Alpha Cognition Appoints Robert Wills as Chairman of the Board as Company Advances ZUNVEYL Launch and Neurodegenerative Pipeline Alpha Cognition Inc. has announced a key leadership transition at the board level, naming Robert Wills as its new Chairman of the…
Arrowhead Pharmaceuticals Wins EU Approval for REDEMPLO® to Lower Triglycerides in Adults with Familial Chylomicronemia Syndrome Arrowhead Pharmaceuticals has secured an important regulatory milestone in Europe with the European Commission’s marketing authorization of REDEMPLO® (plozasiran) for adults living with familial…
Syntax Bio Expands Series A to $14.4 Million, Strengthens Leadership Team and Advances Cell Programming Platform for Type 1 Diabetes Therapies Syntax Bio, a synthetic biology company focused on programming the next generation of cell therapies, has announced a significant…
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…