Category Regulatory

Ropeginterferon Alfa-2b Secures ET Approvals in Key Global Markets, Expanding Patient Access

Ropeginterferon Alfa-2b Gains ET Approvals Across Major Global Markets, Broadening Treatment Access for Patients PharmaEssentia Corporation’s blood cancer treatment, ropeginterferon alfa-2b (Ropeg), is expanding its presence in the global market following regulatory approvals for essential thrombocythemia (ET) in Taiwan, Japan,…

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Avanzanite Bioscience Strengthens UK Operations with Appointment of Sarah O’Connell as Country Manager

Avanzanite Bioscience Expands UK Operations, Appoints Sarah O’Connell as Country Manager to Strengthen Rare Disease Medicine Access Avanzanite Bioscience B.V., a European pharmaceutical company specializing in rare diseases, has announced the expansion of its United Kingdom (UK) operations and the…

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Powerful Medical Secures CPT Code for AI-Powered Heart Attack Detection Following FDA Authorization of Queen of Hearts™

Powerful Medical Secures New CPT Code for Queen of Hearts AI ECG Technology to Detect Heart Attacks Powerful Medical, a company specializing in artificial intelligence (AI)-driven cardiovascular diagnostics, has announced that the American Medical Association (AMA) CPT® Editorial Panel has…

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HeartBeam’s Heart Attack Assessment Technology Accepted into FDA’s TAP Program

HeartBeam’s 3D ECG Technology Accepted into FDA’s TAP Program to Advance Heart Attack Assessment HeartBeam, Inc., a medical technology company focused on transforming cardiac care through advanced cardiac insights, announced that the U.S. Food and Drug Administration (FDA) has accepted…

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Edwards Lifesciences Receives FDA Approval for PASCAL Precision System to Expand Treatment Options for Tricuspid Valve Disease

Edwards Lifesciences Receives FDA Approval for PASCAL Precision System for Tricuspid Valve Repair Edwards Lifesciences Corporation (NYSE: EW), a global developer of patient-focused innovations for structural heart disease, has announced that the U.S. Food and Drug Administration (FDA) has approved…

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Cosette Pharmaceuticals Secures FDA Approval for EVOXAC® Oral Solution, Marking First NDA Approval

Cosette Pharmaceuticals Receives FDA Approval for EVOXAC® Oral Solution to Treat Dry Mouth in Adults With Sjögren’s Disease Cosette Pharmaceuticals, Inc., a U.S.-based specialty pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved EVOXAC® (cevimeline…

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FDA Approves Genentech’s Tecentriq Combination for Stage III Colon Cancer Adjuvant Treatment

Genentech’s Tecentriq Receives FDA Approval for Adjuvant Treatment of Stage III dMMR Colon Cancer Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and…

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Pfizer’s TUKYSA Regimen Wins FDA Approval for Front-Line Maintenance in HER2+ Metastatic Breast Cancer

FDA Approves Pfizer’s TUKYSA Regimen for First-Line Maintenance in HER2+ Metastatic Breast Cancer Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TUKYSA® (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults…

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Shape Memory Medical Receives ANVISA Approval for IMPEDE Embolization Plug Family in Brazil

Shape Memory Medical Receives ANVISA Authorization for IMPEDE Embolization Plug Portfolio in Brazil Shape Memory Medical Inc., a medical technology company developing volume-expanding shape memory polymer solutions for endovascular embolization, has announced that Brazil’s national health surveillance agency, Agência Nacional…

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