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 »
New Drug ApprovalSanofi’s Tzield (Teplizumab) Gains FDA Priority Review for 1-Year-Old... Sanofi’s Tzield (Teplizumab) Gains FDA Priority Review for 1-Year-Old... Read Post »
New Drug ApprovalMHRA Approves Kostaive (Zapomeran) sa-mRNA COVID Booster for UK Adults-Key ... MHRA Approves Kostaive (Zapomeran) sa-mRNA COVID Booster for UK Adults-Key ... Read Post »
New Drug ApprovalUltragenyx Completes Rolling BLA for First-in-Class DTX401 Gene Therapy in ... Ultragenyx Completes Rolling BLA for First-in-Class DTX401 Gene Therapy in ... Read Post »
New Drug ApprovalFDA Accepts Axsome’s AXS-05 Supplemental NDA and Grants Priority Review f... FDA Accepts Axsome’s AXS-05 Supplemental NDA and Grants Priority Review f... Read Post »
New Drug ApprovalFDA Clears NEREUS, First New Motion Sickness Drug in Decades FDA Clears NEREUS, First New Motion Sickness Drug in Decades Read Post »
New Drug ApprovalUnicycive Resubmits NDA for Oxylanthanum Carbonate for Hyperphosphatemia Ma... Unicycive Resubmits NDA for Oxylanthanum Carbonate for Hyperphosphatemia Ma... Read Post »
New Drug ApprovalFDA Grants Breakthrough Therapy to Ulixacaltamide (PRAX-944) for Essential ... FDA Grants Breakthrough Therapy to Ulixacaltamide (PRAX-944) for Essential ... Read Post »
New Drug ApprovalFirst-in-Class TRPV1 Inhibitor Avarept Approved in Japan for Dry Eye Diseas... First-in-Class TRPV1 Inhibitor Avarept Approved in Japan for Dry Eye Diseas... Read Post »
New Drug Approval ResearchGrifols’ FESILTY (Fibrinogen): Evidence, Safety, and Clinical Use Explain... Grifols’ FESILTY (Fibrinogen): Evidence, Safety, and Clinical Use Explain... Read Post »
New Drug ApprovalENHERTU Approved in China for HER2-Low and HER2-Ultralow Metastatic Breast ... ENHERTU Approved in China for HER2-Low and HER2-Ultralow Metastatic Breast ... Read Post »
New Drug ApprovalFDA Approves YARTEMLEA: First TA-TMA Therapy Post-Stem Cell Transplant FDA Approves YARTEMLEA: First TA-TMA Therapy Post-Stem Cell Transplant Read Post »
New Drug ApprovalIncyte’s Zynyz Receives First Approval in Japan for Advanced SCAC Incyte’s Zynyz Receives First Approval in Japan for Advanced SCAC Read Post »
New Drug ApprovalJapan Expands Pediatric Asthma Treatment with Dupixent Approval Japan Expands Pediatric Asthma Treatment with Dupixent Approval Read Post »
New Drug ApprovalZai Lab Wins China Approval for COBENFY, a First-in-Class Muscarinic Therap... Zai Lab Wins China Approval for COBENFY, a First-in-Class Muscarinic Therap... Read Post »
New Drug ApprovalU.S. FDA Approves Agios’ AQVESME (Mitapivat) as First Treatment for Anemi... U.S. FDA Approves Agios’ AQVESME (Mitapivat) as First Treatment for Anemi... Read Post »
New Drug ApprovalJapan Approves Finerenone for Chronic Heart Failure with Preserved or Mildl... Japan Approves Finerenone for Chronic Heart Failure with Preserved or Mildl... Read Post »
New Drug ApprovalEuropean Commission Approves TREMFYA® (guselkumab) for Paediatric Plaque P... European Commission Approves TREMFYA® (guselkumab) for Paediatric Plaque P... Read Post »
New Drug ApprovalNovo Nordisk’s Wegovy Pill Wins FDA Approval Following OASIS Trial Result... Novo Nordisk’s Wegovy Pill Wins FDA Approval Following OASIS Trial Result... Read Post »
New Drug ApprovalSubcutaneous Lunsumio VELO™ Approved: 75% ORR in Heavily Pretreated Folli... Subcutaneous Lunsumio VELO™ Approved: 75% ORR in Heavily Pretreated Folli... Read Post »
New Drug ApprovalMYQORZO Aficamten FDA Approval: Breakthrough for Symptomatic oHCM Treatment... MYQORZO Aficamten FDA Approval: Breakthrough for Symptomatic oHCM Treatment... Read Post »
New Drug ApprovalFDA Approves Expanded Indication for Johnson & Johnson’s TRUFILL n‑... FDA Approves Expanded Indication for Johnson & Johnson’s TRUFILL n‑... Read Post »
New Drug ApprovalNovo Nordisk Pushes Obesity Innovation Forward With FDA Filing for CagriSem... Novo Nordisk Pushes Obesity Innovation Forward With FDA Filing for CagriSem... Read Post »
New Drug ApprovalinMIND Trial Success: Minjuvi (Tafasitamab) Now EU-Approved for Relapsed Fo... inMIND Trial Success: Minjuvi (Tafasitamab) Now EU-Approved for Relapsed Fo... Read Post »
New Drug ApprovalSaphnelo Gains EU Approval for At-Home Subcutaneous Self-Administration in ... Saphnelo Gains EU Approval for At-Home Subcutaneous Self-Administration in ... Read Post »
New Drug ApprovalAddyi FDA Approval 2025: Now for Postmenopausal Women with Low Libido Addyi FDA Approval 2025: Now for Postmenopausal Women with Low Libido Read Post »
New Drug ApprovalBreakthrough PCSK9 Inhibitor LEROCHOL Approved for Hypercholesterolemia Breakthrough PCSK9 Inhibitor LEROCHOL Approved for Hypercholesterolemia Read Post »
