New Drug ApprovalExdensur (Depemokimab) Secures First Global Approval in the UK, Followed by... Exdensur (Depemokimab) Secures First Global Approval in the UK, Followed by... Read Post »
New Drug ApprovalFDA Approves CARDAMYST™ (Etripamil) as First Self-Administered Nasal Spra... FDA Approves CARDAMYST™ (Etripamil) as First Self-Administered Nasal Spra... Read Post »
New Drug ApprovalNew FDA Approval: Uplizna for gMG in Adults New FDA Approval: Uplizna for gMG in Adults Read Post »
New Drug ApprovalEMA CHMP December 2025 Meeting: 7 New Medicine Approvals and 12 Indication ... EMA CHMP December 2025 Meeting: 7 New Medicine Approvals and 12 Indication ... Read Post »
New Drug ApprovalFDA Approves Nuzolvence (Zoliflodacin): First-in-Class Oral Antibiotic for ... FDA Approves Nuzolvence (Zoliflodacin): First-in-Class Oral Antibiotic for ... Read Post »
New Drug ApprovalFDA Approves First Cell-Based Therapy Waskyra for Rare WAS Immunodeficiency FDA Approves First Cell-Based Therapy Waskyra for Rare WAS Immunodeficiency Read Post »
New Drug ApprovalFDA’s First CNPV Approval: Augmentin XR Goes Domestic FDA’s First CNPV Approval: Augmentin XR Goes Domestic Read Post »
New Drug ApprovalFDA Qualifies First AI Tool under Drug Development Tool Program, Paving the... FDA Qualifies First AI Tool under Drug Development Tool Program, Paving the... Read Post »
New Drug ApprovalFDA Approves Omisirge for Severe Aplastic Anemia: A New Option for Patients... FDA Approves Omisirge for Severe Aplastic Anemia: A New Option for Patients... Read Post »
New Drug ApprovalFDA Approves Breyanzi as First CAR T-Cell Therapy for Relapsed/Refractory M... FDA Approves Breyanzi as First CAR T-Cell Therapy for Relapsed/Refractory M... Read Post »
Clinical Trails New Drug ApprovalIonis’ Zilganersen Earns FDA Breakthrough Therapy Designation for Ultra R... Ionis’ Zilganersen Earns FDA Breakthrough Therapy Designation for Ultra R... Read Post »
New Drug ApprovalSun Pharma Launches Ilumya® in India: A Global Innovative Drug for Moderat... Sun Pharma Launches Ilumya® in India: A Global Innovative Drug for Moderat... Read Post »
New Drug ApprovalBaxdrostat NDA Accepted Under FDA Priority Review for Hard-to-Control High ... Baxdrostat NDA Accepted Under FDA Priority Review for Hard-to-Control High ... Read Post »
New Drug ApprovalAmneal Secure FDA Nod for Albuterol Inhaler and Cyclosporine Eye Drops in E... Amneal Secure FDA Nod for Albuterol Inhaler and Cyclosporine Eye Drops in E... Read Post »
New Drug ApprovalUS FDA Accepts Wockhardt’s NDA for Zaynich, Marking a Historic First for ... US FDA Accepts Wockhardt’s NDA for Zaynich, Marking a Historic First for ... Read Post »
New Drug ApprovalChina’s First Domestic IL-23p19 Antibody PECONDLE Gains NMPA Approval... China’s First Domestic IL-23p19 Antibody PECONDLE Gains NMPA Approval... Read Post »
New Drug ApprovalTreating ADHD Across Lifespan: Otsuka’s Centanafadine NDA Submission Insi... Treating ADHD Across Lifespan: Otsuka’s Centanafadine NDA Submission Insi... Read Post »
New Drug ApprovalEisai Completes Fast Track sBLA to FDA and Submits NDA to Japan PMDA for Su... Eisai Completes Fast Track sBLA to FDA and Submits NDA to Japan PMDA for Su... Read Post »
New Drug ApprovalFDA Accelerates Approval of Otsuka’s VOYXACT® (sibeprenlimab-szsi) for I... FDA Accelerates Approval of Otsuka’s VOYXACT® (sibeprenlimab-szsi) for I... Read Post »
Clinical Trails New Drug ApprovalNovo Nordisk Files FDA sNDA for Wegovy 7.2 mg Higher Dose After 20.7% Weigh... Novo Nordisk Files FDA sNDA for Wegovy 7.2 mg Higher Dose After 20.7% Weigh... Read Post »
New Drug ApprovalFDA Approves Imfinzi as First and Only Perioperative Immunotherapy for Earl... FDA Approves Imfinzi as First and Only Perioperative Immunotherapy for Earl... Read Post »
New Drug ApprovalSanofi and Regeneron’s Dupixent Wins EU Approval as First Targeted Therap... Sanofi and Regeneron’s Dupixent Wins EU Approval as First Targeted Therap... Read Post »
New Drug ApprovalSerum Institute of India’s SIILTIBCY® Receives MHRA Authorization in... Serum Institute of India’s SIILTIBCY® Receives MHRA Authorization in... Read Post »
New Drug ApprovalFDA Approves Itvisma (Onasemnogene Abeparvovec-brve), the First Intrathecal... FDA Approves Itvisma (Onasemnogene Abeparvovec-brve), the First Intrathecal... Read Post »
New Drug ApprovalKoselugo Approved by FDA for Adults with Neurofibromatosis Type 1: A New Tr... Koselugo Approved by FDA for Adults with Neurofibromatosis Type 1: A New Tr... Read Post »
New Drug ApprovalFDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ with Padcev® ... FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ with Padcev® ... Read Post »
New Drug ApprovalFDA Grants Full Approval to AbbVie’s EPKINLY® (epcoritamab-bysp) Plu... FDA Grants Full Approval to AbbVie’s EPKINLY® (epcoritamab-bysp) Plu... Read Post »
New Drug ApprovalFDA Clears Regeneron and Bayer’s EYLEA HD® for Macular Edema after R... FDA Clears Regeneron and Bayer’s EYLEA HD® for Macular Edema after R... Read Post »
New Drug ApprovalFDA Approves Redemplo (Plozasiran) to Lower Triglycerides in Adults with Fa... FDA Approves Redemplo (Plozasiran) to Lower Triglycerides in Adults with Fa... Read Post »
New Drug ApprovalEMA CHMP November 2025: Ten New Medicines Recommended for Approval EMA CHMP November 2025: Ten New Medicines Recommended for Approval Read Post »
New Drug ApprovalSandoz Launches Tyruko® in US, First Biosimilar to Biogen’s Tysabri, Enh... Sandoz Launches Tyruko® in US, First Biosimilar to Biogen’s Tysabri, Enh... Read Post »
New Drug ApprovalFDA Approves Linzess (Linaclotide) for Pediatric IBS-C: A Game Changer in T... FDA Approves Linzess (Linaclotide) for Pediatric IBS-C: A Game Changer in T... Read Post »
New Drug ApprovalInnovative Brekiya® DHE Autoinjector Launched by Amneal for Rapid Relief o... Innovative Brekiya® DHE Autoinjector Launched by Amneal for Rapid Relief o... Read Post »
New Drug ApprovalKygevvi Brings Hope for Patients With Rare Mitochondrial Disorder Kygevvi Brings Hope for Patients With Rare Mitochondrial Disorder Read Post »
Disease & Drugs New Drug ApprovalNew FDA Indication for WINREVAIR: Reducing Hospitalizations and Mortality i... New FDA Indication for WINREVAIR: Reducing Hospitalizations and Mortality i... Read Post »
New Drug ApprovalBayer’s Lynkuet: FDA Approves Non-Hormonal Pill for Hot Flashes in Menopa... Bayer’s Lynkuet: FDA Approves Non-Hormonal Pill for Hot Flashes in Menopa... Read Post »
New Drug ApprovalLupin Launches Authorized Generic and Endo Launches First Generic Versions ... Lupin Launches Authorized Generic and Endo Launches First Generic Versions ... Read Post »
New Drug ApprovalFDA Re-approves GSK’s Blenrep (Belantamab Mafodotin-blmf) Combo for Relap... FDA Re-approves GSK’s Blenrep (Belantamab Mafodotin-blmf) Combo for Relap... Read Post »
New Drug ApprovalFDA Expands Approval of Revumenib for NPM1-Mutated Relapsed or Refractory A... FDA Expands Approval of Revumenib for NPM1-Mutated Relapsed or Refractory A... Read Post »
Health Tidings New Drug ApprovalMounjaro Now Cipla’s Yurpeak: A New Chapter for Tirzepatide in India Mounjaro Now Cipla’s Yurpeak: A New Chapter for Tirzepatide in India Read Post »
New Drug ApprovalGlaukos’ Epioxa™ Wins FDA Nod: A Game-Changer for Keratoconus Patients Glaukos’ Epioxa™ Wins FDA Nod: A Game-Changer for Keratoconus Patients Read Post »
New Drug ApprovalFDA Approves Gazyva for Lupus Nephritis, Extending Roche and Biogen’s CD2... FDA Approves Gazyva for Lupus Nephritis, Extending Roche and Biogen’s CD2... Read Post »
New Drug ApprovalFDA Approves Lasix ONYU: At-Home Drug-Device Combination for Subcutaneous F... FDA Approves Lasix ONYU: At-Home Drug-Device Combination for Subcutaneous F... Read Post »
New Drug ApprovalFDA Approves Libtayo® (cemiplimab-rwlc) for Adjuvant Treatment of High-Ris... FDA Approves Libtayo® (cemiplimab-rwlc) for Adjuvant Treatment of High-Ris... Read Post »
New Drug ApprovalFDA Clears Simponi (Golimumab) for Children with Ulcerative Colitis FDA Clears Simponi (Golimumab) for Children with Ulcerative Colitis Read Post »
New Drug ApprovalJascayd (Nerandomilast) Receives FDA Nod for Idiopathic Pulmonary Fibrosis Jascayd (Nerandomilast) Receives FDA Nod for Idiopathic Pulmonary Fibrosis Read Post »
Clinical Trails New Drug ApprovalFDA Approves Arcutis’ Zoryve (Roflumilast) Cream 0.05% for Mild to Modera... FDA Approves Arcutis’ Zoryve (Roflumilast) Cream 0.05% for Mild to Modera... Read Post »
Clinical Trails New Drug ApprovalIntroducing Ozempic in India: A Breakthrough in Type 2 Diabetes and Weight ... Introducing Ozempic in India: A Breakthrough in Type 2 Diabetes and Weight ... Read Post »
Clinical Trails New Drug ApprovalFDA Approves Jazz’s Zepzelca plus Roche’s Tecentriq for Extensive-S... FDA Approves Jazz’s Zepzelca plus Roche’s Tecentriq for Extensive-S... Read Post »
Clinical Trails New Drug ApprovalFDA Approval of Rhapsido® (remibrutinib) for Chronic Spontaneous Urticaria... FDA Approval of Rhapsido® (remibrutinib) for Chronic Spontaneous Urticaria... Read Post »
