New Drug ApprovalChugai report Anti-CD20 Monoclonal Antibody Rituxan® Approved for AIHA Chugai report Anti-CD20 Monoclonal Antibody Rituxan® Approved for AIHA Read Post »
New Drug ApprovalAbbVie’s VENCLEXTA Taps AZ’s Acalabrutinib for FDA’s Firs... AbbVie’s VENCLEXTA Taps AZ’s Acalabrutinib for FDA’s Firs... Read Post »
New Drug ApprovalEuropean Commission Grants Conditional Approval for ANKTIVA® in BCG-Unresp... European Commission Grants Conditional Approval for ANKTIVA® in BCG-Unresp... Read Post »
New Drug ApprovalFDA Approves Simplified Monthly Dosing for RYBREVANT FASPRO™ in EGFR-Muta... FDA Approves Simplified Monthly Dosing for RYBREVANT FASPRO™ in EGFR-Muta... Read Post »
New Drug ApprovalGSK’s Exdensur Gains EU Approval for Severe Asthma and CRSwNP GSK’s Exdensur Gains EU Approval for Severe Asthma and CRSwNP Read Post »
New Drug ApprovalAmgen’s UPLIZNA® Approved for gMG in EU Amgen’s UPLIZNA® Approved for gMG in EU Read Post »
New Drug ApprovalKEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ Approved in Combination The... KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ Approved in Combination The... Read Post »
New Drug ApprovalNovocure’s Optune Pax Receives FDA Approval in Pancreatic Cancer Novocure’s Optune Pax Receives FDA Approval in Pancreatic Cancer Read Post »
New Drug ApprovalGSK’s Nucala Secures European Approval for Eosinophilic COPD GSK’s Nucala Secures European Approval for Eosinophilic COPD Read Post »
New Drug ApprovalFDA Approves VYBRIQUE as First Oral Film for Erectile Dysfunction FDA Approves VYBRIQUE as First Oral Film for Erectile Dysfunction Read Post »
New Drug ApprovalAbbVie Seeks FDA, EMA Approval of RINVOQ in Vitiligo AbbVie Seeks FDA, EMA Approval of RINVOQ in Vitiligo Read Post »
New Drug ApprovalBayer’s Nubeqa Approved for mHSPC in China Bayer’s Nubeqa Approved for mHSPC in China Read Post »
New Drug ApprovalImfinzi Boosts Survival in Gastric Cancer, Gains CHMP Endorsement Imfinzi Boosts Survival in Gastric Cancer, Gains CHMP Endorsement Read Post »
New Drug ApprovalCHMP Backs Rezurock for Chronic GVHD After Re-Examination CHMP Backs Rezurock for Chronic GVHD After Re-Examination Read Post »
New Drug ApprovalIncyte’s Zynyz Wins Positive CHMP Opinion in Advanced Anal Cancer Incyte’s Zynyz Wins Positive CHMP Opinion in Advanced Anal Cancer Read Post »
New Drug ApprovalEMA CHMP Recommends Bayer’s Finerenone for Heart Failure with LVEF â‰... EMA CHMP Recommends Bayer’s Finerenone for Heart Failure with LVEF â‰... Read Post »
New Drug ApprovalJ&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer J&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer Read Post »
New Drug ApprovalFDA Approves Tenpoint’s YUVEZZI Eye Drop for Presbyopia Treatment FDA Approves Tenpoint’s YUVEZZI Eye Drop for Presbyopia Treatment Read Post »
New Drug ApprovalFDA Approves JnJ’s DARZALEX FASPRO Quadruplet for NDMM FDA Approves JnJ’s DARZALEX FASPRO Quadruplet for NDMM Read Post »
New Drug ApprovalEU Expands GSK’s Arexvy Approval to All Adults Aged 18 and Older EU Expands GSK’s Arexvy Approval to All Adults Aged 18 and Older Read Post »
New Drug ApprovalSun Pharma Wins DCGI Approval for Noveltreat, Generic Semaglutide Injection... Sun Pharma Wins DCGI Approval for Noveltreat, Generic Semaglutide Injection... Read Post »
New Drug ApprovalGSK’s Trelegy Ellipta Approved by NMPA in China for Adult Asthma GSK’s Trelegy Ellipta Approved by NMPA in China for Adult Asthma Read Post »
New Drug ApprovalEMA Validates ENHERTU Plus Pertuzumab for First-Line HER2 Positive Metastat... EMA Validates ENHERTU Plus Pertuzumab for First-Line HER2 Positive Metastat... Read Post »
New Drug ApprovalNMPA Review Begins for Envafolimab NDA in Biliary Cancer NMPA Review Begins for Envafolimab NDA in Biliary Cancer Read Post »
New Drug ApprovalEU Approves Eylea 8 mg for Retinal Vein Occlusion After Durable Results in ... EU Approves Eylea 8 mg for Retinal Vein Occlusion After Durable Results in ... Read Post »
New Drug ApprovalAtossa Therapeutics Secures FDA Orphan Drug Designation for (Z)-Endoxifen i... Atossa Therapeutics Secures FDA Orphan Drug Designation for (Z)-Endoxifen i... Read Post »
New Drug ApprovalNovartis’ Ianalumab Secures FDA Breakthrough Therapy Designation for Sjö... Novartis’ Ianalumab Secures FDA Breakthrough Therapy Designation for Sjö... Read Post »
New Drug ApprovalChina NMPA Approves Two Sanofi-Licensed Innovative Therapies: Myqorzo (Afic... China NMPA Approves Two Sanofi-Licensed Innovative Therapies: Myqorzo (Afic... Read Post »
New Drug ApprovalAbbisko Therapeutics Achieves Major Milestone as FDA Accepts NDA for Pimico... Abbisko Therapeutics Achieves Major Milestone as FDA Accepts NDA for Pimico... Read Post »
New Drug ApprovalSebela Submits NDA for Tegoprazan as Potential First-in-Class P-CAB for GER... Sebela Submits NDA for Tegoprazan as Potential First-in-Class P-CAB for GER... Read Post »
New Drug ApprovalBiogen’s High-Dose SPINRAZA Approved in EU Following DEVOTE Study Results Biogen’s High-Dose SPINRAZA Approved in EU Following DEVOTE Study Results Read Post »
New Drug ApprovalGSK Receives EU Approval for Ready-to-Use Prefilled Syringe Shingrix GSK Receives EU Approval for Ready-to-Use Prefilled Syringe Shingrix Read Post »
New Drug ApprovalFDA Accepts Camurus NDA Resubmission for Oclaiz™ in Acromegaly Treatment FDA Accepts Camurus NDA Resubmission for Oclaiz™ in Acromegaly Treatment Read Post »
New Drug ApprovalFDA Approves Zycubo (Copper Histidinate) Injection as First-Ever Treatment ... FDA Approves Zycubo (Copper Histidinate) Injection as First-Ever Treatment ... Read Post »
New Drug ApprovalFDA Grants Breakthrough Therapy Designation to Encoded Therapeutics’ ETX1... FDA Grants Breakthrough Therapy Designation to Encoded Therapeutics’ ETX1... Read Post »
New Drug ApprovalSanofi’s Teizeild Approved in EU to Delay Stage 3 Type 1 Diabetes Onset i... Sanofi’s Teizeild Approved in EU to Delay Stage 3 Type 1 Diabetes Onset i... Read Post »
New Drug ApprovalBayer’s Sevabertinib Gets Fast-Track Status in U.S. and China for HER2-Mu... Bayer’s Sevabertinib Gets Fast-Track Status in U.S. and China for HER2-Mu... Read Post »
New Drug ApprovalChina Grants First-in-World Approval to BeOne Medicines’ Sonrotoclax ... China Grants First-in-World Approval to BeOne Medicines’ Sonrotoclax ... Read Post »
New Drug ApprovalMilestone’s Etripamil Nasal Spray Accepted for EMA Review in PSVT Milestone’s Etripamil Nasal Spray Accepted for EMA Review in PSVT Read Post »
New Drug ApprovalFDA expands Cablivi approval to pediatric patients aged 12 and older with a... FDA expands Cablivi approval to pediatric patients aged 12 and older with a... Read Post »
New Drug ApprovalTakeda and Protagonist Submit NDA to FDA for Rusfertide in Polycythemia Ver... Takeda and Protagonist Submit NDA to FDA for Rusfertide in Polycythemia Ver... Read Post »
New Drug ApprovalFDA Grants Priority Review to Vera Therapeutics’ Atacicept for IgA Nephro... FDA Grants Priority Review to Vera Therapeutics’ Atacicept for IgA Nephro... Read Post »
New Drug ApprovalJapan Approves Exdensur After U.S. and UK, Expanding Access for Severe Asth... Japan Approves Exdensur After U.S. and UK, Expanding Access for Severe Asth... Read Post »
New Drug ApprovalZai Lab’s AUGTYRO (repotrectinib) Receives NMPA Approval for NTRK-Positiv... Zai Lab’s AUGTYRO (repotrectinib) Receives NMPA Approval for NTRK-Positiv... Read Post »
New Drug ApprovalChina Accepts BLA for Subcutaneous LEQEMBI for Early Alzheimer’s China Accepts BLA for Subcutaneous LEQEMBI for Early Alzheimer’s Read Post »
New Drug ApprovalHealth Canada Approves REDEMPLO (plozasiran) for Familial Chylomicronemia S... Health Canada Approves REDEMPLO (plozasiran) for Familial Chylomicronemia S... Read Post »
New Drug ApprovalModerna Files With FDA, EMA, Health Canada and TGA for New mRNA Flu Shot Moderna Files With FDA, EMA, Health Canada and TGA for New mRNA Flu Shot Read Post »
New Drug ApprovalAltimmune’s Pemvidutide Granted FDA Breakthrough Therapy Designation for ... Altimmune’s Pemvidutide Granted FDA Breakthrough Therapy Designation for ... Read Post »
New Drug ApprovalGSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic... GSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic... Read Post »
