Approvals

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3 hours ago3 min read

Merck’s Lipfendra Becomes First FDA-Approved Oral PCSK9 Inhibitor for High Cholesterol

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2 days ago3 min read

FDA Approves Celcuity’s Revtorpyk for PI3K-Pathway Targeted Breast Cancer Treatment

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3 days ago3 min read

Claria Medical Secures FDA De Novo Clearance for Hysterectomy Tissue Extraction System

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4 days ago3 min read

FDA Clears iHealthScreen’s AI Diabetic Retinopathy Screening Software

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4 days ago3 min read

FDA Clears Zeta Surgical’s AI-Powered Robotic TMS Navigation System for Treatment-Resistant Depression

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4 days ago4 min read

FDA Approves MSD’s Keytruda Combinations with Padcev for Muscle-Invasive Bladder Cancer

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4 days ago3 min read

Sanofi’s Sarclisa Escena Receives FDA Approval as First Oncology Drug Delivered Through On-Body Injector

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7 days ago3 min read

FDA Approves Subcutaneous Sarclisa (Isatuximab-Irfc) for Multiple Myeloma Treatment

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7 days ago3 min read

FDA Approves Johnson & Johnson's Dual-Energy Catheter Ablation Platform

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7 days ago2 min read

Roche Secures CE Mark for Automated Blood Test to Detect Latent Tuberculosis

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Jul 102 min read

FDA Approves Accord BioPharma's ENNUMO Biosimilar to Neulasta

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Jul 82 min read

FDA Approves Trutakna as First Dual BAFF/APRIL Targeted Therapy for IgA Nephropathy

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Jul 73 min read

UK Expands Wegovy Approval to Include MASH Treatment

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Jul 32 min read

European Commission Expands Approval of Novartis' Itvisma for Broader SMA Patient Population

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Jul 22 min read

FDA Approves First Regulatory T-Cell Therapy for Chronic GVHD Prevention

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Jun 152 min read

FDA backs Merck’s dual-pronged push in kidney cancer with Welireg–Keytruda combo approval

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Jun 22 min read

FDA Approves AstraZeneca’s Imfinzi Plus BCG for High-Risk Bladder Cancer

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May 182 min read

FDA Approves Roche’s Tecentriq in First ctDNA-Guided Cancer Therapy

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May 61 min read

Novo Nordisk Launches Oral Ozempic in US Diabetes Market

nuaxia

Apr 81 min read

Merck’s Lipfendra Becomes First FDA-Approved Oral PCSK9 Inhibitor for High Cholesterol

FDA Approves Celcuity’s Revtorpyk for PI3K-Pathway Targeted Breast Cancer Treatment

Claria Medical Secures FDA De Novo Clearance for Hysterectomy Tissue Extraction System

FDA Clears iHealthScreen’s AI Diabetic Retinopathy Screening Software

FDA Clears Zeta Surgical’s AI-Powered Robotic TMS Navigation System for Treatment-Resistant Depression

FDA Approves MSD’s Keytruda Combinations with Padcev for Muscle-Invasive Bladder Cancer

Sanofi’s Sarclisa Escena Receives FDA Approval as First Oncology Drug Delivered Through On-Body Injector

FDA Approves Subcutaneous Sarclisa (Isatuximab-Irfc) for Multiple Myeloma Treatment

FDA Approves Johnson & Johnson's Dual-Energy Catheter Ablation Platform

Roche Secures CE Mark for Automated Blood Test to Detect Latent Tuberculosis

FDA Approves Accord BioPharma's ENNUMO Biosimilar to Neulasta

FDA Approves Trutakna as First Dual BAFF/APRIL Targeted Therapy for IgA Nephropathy

UK Expands Wegovy Approval to Include MASH Treatment

European Commission Expands Approval of Novartis' Itvisma for Broader SMA Patient Population

FDA Approves First Regulatory T-Cell Therapy for Chronic GVHD Prevention

FDA backs Merck’s dual-pronged push in kidney cancer with Welireg–Keytruda combo approval

FDA Approves AstraZeneca’s Imfinzi Plus BCG for High-Risk Bladder Cancer

FDA Approves Roche’s Tecentriq in First ctDNA-Guided Cancer Therapy

Novo Nordisk Launches Oral Ozempic in US Diabetes Market

MSD Secures European Approval for Keytruda Combination Therapy in Ovarian Cancer