New Drug ApprovalEC Approves ENFLONSIA for RSV Prevention in Infants Across Europe EC Approves ENFLONSIA for RSV Prevention in Infants Across Europe Read Post »
New Drug ApprovalNICE Backs Belantamab Mafodotin for Relapsed Multiple Myeloma in NHS NICE Backs Belantamab Mafodotin for Relapsed Multiple Myeloma in NHS Read Post »
New Drug ApprovalFDA Clears Expanded Use of Caldolor for Postoperative Pain Treatment FDA Clears Expanded Use of Caldolor for Postoperative Pain Treatment Read Post »
New Drug ApprovalFILSPARI Unlocks the Door for FSGS With First FDA Approval FILSPARI Unlocks the Door for FSGS With First FDA Approval Read Post »
New Drug ApprovalDupixent Extends Its Reach to Young CSU Patients in EU Dupixent Extends Its Reach to Young CSU Patients in EU Read Post »
New Drug ApprovalMHRA Unleashes Tryngolza to Break the Triglyceride Surge in FCS MHRA Unleashes Tryngolza to Break the Triglyceride Surge in FCS Read Post »
New Drug ApprovalChina Approves GSK’s Exdensur for Chronic Rhinosinusitis with Nasal Polyp... China Approves GSK’s Exdensur for Chronic Rhinosinusitis with Nasal Polyp... Read Post »
New Drug ApprovalSenju Commercializes Avarept 0.3% for Dry Eye Disease in Japan Senju Commercializes Avarept 0.3% for Dry Eye Disease in Japan Read Post »
New Drug ApprovalMHRA Approves Sevabertinib for HER2+ Lung Cancer MHRA Approves Sevabertinib for HER2+ Lung Cancer Read Post »
New Drug ApprovalEU Approves First PD-1–Based Regimen KEYTRUDA for Platinum-Resistant Ovar... EU Approves First PD-1–Based Regimen KEYTRUDA for Platinum-Resistant Ovar... Read Post »
New Drug ApprovalRegeneron Pharmaceuticals Secures FDA Nod for Extended EYLEA HD Dosing Up t... Regeneron Pharmaceuticals Secures FDA Nod for Extended EYLEA HD Dosing Up t... Read Post »
New Drug ApprovalFDA Converts Tecartus Approval to Full Approval in Mantle Cell Lymphoma Fol... FDA Converts Tecartus Approval to Full Approval in Mantle Cell Lymphoma Fol... Read Post »
New Drug ApprovalLilly Brings Weight-Loss Pill to Market with Foundayo FDA Approval Lilly Brings Weight-Loss Pill to Market with Foundayo FDA Approval Read Post »
New Drug ApprovalBiogen’s High-Dose Spinraza Approved by FDA Backed by DEVOTE Data Biogen’s High-Dose Spinraza Approved by FDA Backed by DEVOTE Data Read Post »
New Drug ApprovalCHMP Recommends Five New Medicines for EU Approval in March 2026 CHMP Recommends Five New Medicines for EU Approval in March 2026 Read Post »
New Drug ApprovalChina Approves ENHERTU as First HER2 ADC for Neoadjuvant Breast Cancer China Approves ENHERTU as First HER2 ADC for Neoadjuvant Breast Cancer Read Post »
New Drug ApprovalNovo Nordisk Wins FDA Approval for Once-Weekly Basal Insulin Awiqli Novo Nordisk Wins FDA Approval for Once-Weekly Basal Insulin Awiqli Read Post »
New Drug ApprovalFDA Grants Accelerated Approval to Rocket’s Kresladi Gene Therapy for... FDA Grants Accelerated Approval to Rocket’s Kresladi Gene Therapy for... Read Post »
New Drug ApprovalCorcept’s Relacorilant Combo Approved for Resistant Ovarian Cancer Corcept’s Relacorilant Combo Approved for Resistant Ovarian Cancer Read Post »
New Drug ApprovalFDA Clears Denali’s AVLAYAH, First Brain-Penetrant Therapy for Hunter... FDA Clears Denali’s AVLAYAH, First Brain-Penetrant Therapy for Hunter... Read Post »
New Drug ApprovalJapan Approves Dupixent for Adults with Bullous Pemphigoid Japan Approves Dupixent for Adults with Bullous Pemphigoid Read Post »
New Drug ApprovalPharming’s Joenja Approved in Japan as First Treatment for APDS Pharming’s Joenja Approved in Japan as First Treatment for APDS Read Post »
Generics New Drug ApprovalViatris’ Effexor SR Becomes First Approved Treatment for Generalized Anxi... Viatris’ Effexor SR Becomes First Approved Treatment for Generalized Anxi... Read Post »
New Drug ApprovalNivolumab Plus AVD Approved by FDA as Frontline Therapy for Advanced cHL Nivolumab Plus AVD Approved by FDA as Frontline Therapy for Advanced cHL Read Post »
New Drug ApprovalFDA Approves IMCIVREE as First Therapy for Acquired Hypothalamic Obesity FDA Approves IMCIVREE as First Therapy for Acquired Hypothalamic Obesity Read Post »
New Drug ApprovalWegovy HD Approved by FDA After Trials Show ~21% Weight Loss Wegovy HD Approved by FDA After Trials Show ~21% Weight Loss Read Post »
New Drug ApprovalFDA Approves GSK’s Lynavoy as First Treatment for PBC-Related Itch FDA Approves GSK’s Lynavoy as First Treatment for PBC-Related Itch Read Post »
New Drug ApprovalJ&J’s Oral IL-23 Therapy ICOTYDE Wins FDA Approval for Plaque Psorias... J&J’s Oral IL-23 Therapy ICOTYDE Wins FDA Approval for Plaque Psorias... Read Post »
New Drug ApprovalAstraZeneca’s Imfinzi Combo Approved in EU for Gastric Cancer AstraZeneca’s Imfinzi Combo Approved in EU for Gastric Cancer Read Post »
New Drug ApprovalChina Approves Zydus’ Desidustat for Renal Anaemia in Chronic Kidney Dise... China Approves Zydus’ Desidustat for Renal Anaemia in Chronic Kidney Dise... Read Post »
New Drug ApprovalFDA Broadens Use of GSK’s Arexvy to At-Risk Adults 18–49 FDA Broadens Use of GSK’s Arexvy to At-Risk Adults 18–49 Read Post »
New Drug ApprovalCosentyx Becomes First IL-17A Inhibitor Approved for Adolescents in Hidrade... Cosentyx Becomes First IL-17A Inhibitor Approved for Adolescents in Hidrade... Read Post »
New Drug ApprovalFDA Approves Johnson & Johnson’s TECNIS PureSee IOL for Cataract Surg... FDA Approves Johnson & Johnson’s TECNIS PureSee IOL for Cataract Surg... Read Post »
New Drug ApprovalJ&J’s Niraparib–Abiraterone Combo Approved in EU for BRCA-Mutated m... J&J’s Niraparib–Abiraterone Combo Approved in EU for BRCA-Mutated m... Read Post »
New Drug ApprovalEuropean Commission Approves Every-4-Week Dosing of Pegunigalsidase Alfa fo... European Commission Approves Every-4-Week Dosing of Pegunigalsidase Alfa fo... Read Post »
New Drug ApprovalFDA Approves Wellcovorin (Leucovorin Calcium) as First Treatment for Rare F... FDA Approves Wellcovorin (Leucovorin Calcium) as First Treatment for Rare F... Read Post »
New Drug ApprovalFDA Approves PYLARIFY TruVu for PSMA PET Imaging in Prostate Cancer FDA Approves PYLARIFY TruVu for PSMA PET Imaging in Prostate Cancer Read Post »
New Drug ApprovalEuropean Commission Approves Incyte’s Zynyz Combination Therapy for First... European Commission Approves Incyte’s Zynyz Combination Therapy for First... Read Post »
New Drug ApprovalFDA Approves Bristol Myers Squibb’s Sotyktu as First TYK2 Inhibitor for A... FDA Approves Bristol Myers Squibb’s Sotyktu as First TYK2 Inhibitor for A... Read Post »
New Drug ApprovalJ&J’s TECVAYLI–DARZALEX FASPRO Combo Wins FDA Approval After MajesT... J&J’s TECVAYLI–DARZALEX FASPRO Combo Wins FDA Approval After MajesT... Read Post »
New Drug ApprovalGlenmark Secures FDA Approval and CGT Exclusivity for Generic Fluticasone Glenmark Secures FDA Approval and CGT Exclusivity for Generic Fluticasone Read Post »
New Drug ApprovalAgios’ PYRUKYND Gains UAE Approval as First Therapy for Thalassemia P... Agios’ PYRUKYND Gains UAE Approval as First Therapy for Thalassemia P... Read Post »
New Drug ApprovalHERNEXEOS® Gains FDA Nod as First-Line Option for HER2-Mutant NSCLC HERNEXEOS® Gains FDA Nod as First-Line Option for HER2-Mutant NSCLC Read Post »
New Drug ApprovalFDA Approves Once-Weekly YUVIWEL® for Pediatric Achondroplasia FDA Approves Once-Weekly YUVIWEL® for Pediatric Achondroplasia Read Post »
New Drug ApprovalFDA Approves BioMarin PALYNZIQ for Adolescents with PKU FDA Approves BioMarin PALYNZIQ for Adolescents with PKU Read Post »
New Drug ApprovalJ&J Seeks FDA Approval of IMAAVY® as First Treatment for wAIHA J&J Seeks FDA Approval of IMAAVY® as First Treatment for wAIHA Read Post »
New Drug ApprovalFDA Grants Full Approval to Pfizer’s BRAFTOVI Regimen FDA Grants Full Approval to Pfizer’s BRAFTOVI Regimen Read Post »
New Drug ApprovalDupixent Approved by FDA: Sanofi & Regeneron’s First Treatment fo... Dupixent Approved by FDA: Sanofi & Regeneron’s First Treatment fo... Read Post »
New Drug ApprovalFDA Approves Zepbound 4-Dose KwikPen for Obesity Care FDA Approves Zepbound 4-Dose KwikPen for Obesity Care Read Post »
New Drug ApprovalFDA Approves BYSANTI™: A New Ally in Bipolar I and Schizophrenia Treatmen... FDA Approves BYSANTI™: A New Ally in Bipolar I and Schizophrenia Treatmen... Read Post »
