New Drug ApprovalFirst New ET Treatment in Nearly 30 Years: BESREMi Wins FDA Approval First New ET Treatment in Nearly 30 Years: BESREMi Wins FDA Approval Read Post »
New Drug ApprovalNew Hope for Polycythemia Vera: FDA Approves MIMRYLO New Hope for Polycythemia Vera: FDA Approves MIMRYLO Read Post »
New Drug ApprovalFDA Approves Bixlenvo, First Single-Tablet HIV Regimen for Patients on Comp... FDA Approves Bixlenvo, First Single-Tablet HIV Regimen for Patients on Comp... Read Post »
New Drug ApprovalFDA Approves LISRAYA as First Targeted Oral Therapy for Adults with Dermato... FDA Approves LISRAYA as First Targeted Oral Therapy for Adults with Dermato... Read Post »
New Drug ApprovalModerna Secures FDA Approval for XFG-Updated Spikevax and mNEXSPIKE for 202... Moderna Secures FDA Approval for XFG-Updated Spikevax and mNEXSPIKE for 202... Read Post »
New Drug ApprovalHUTCHMED Secures NMPA Conditional Approval for ATLED® (Fanregratinib) in F... HUTCHMED Secures NMPA Conditional Approval for ATLED® (Fanregratinib) in F... Read Post »
New Drug ApprovalRevolution Medicines’ RASONQUE (Daraxonrasib) Becomes First Approved RAS(... Revolution Medicines’ RASONQUE (Daraxonrasib) Becomes First Approved RAS(... Read Post »
New Drug ApprovalFDA Approves Tivicay PD for HIV-1 Treatment in Babies from Birth FDA Approves Tivicay PD for HIV-1 Treatment in Babies from Birth Read Post »
New Drug ApprovalZiihera Plus Tislelizumab Approved for HER2-Positive GEA Without PD-L1 Requ... Ziihera Plus Tislelizumab Approved for HER2-Positive GEA Without PD-L1 Requ... Read Post »
New Drug ApprovalGC Green Cross Secures Hunterase Approvals for Hunter Syndrome in India and... GC Green Cross Secures Hunterase Approvals for Hunter Syndrome in India and... Read Post »
New Drug ApprovalORZEYFUL Approved in Japan as First and Only Medicine to Treat the Underlyi... ORZEYFUL Approved in Japan as First and Only Medicine to Treat the Underlyi... Read Post »
New Drug ApprovalFDA Approves IMAAVY® (nipocalimab-aahu) as the First Approved Treatment fo... FDA Approves IMAAVY® (nipocalimab-aahu) as the First Approved Treatment fo... Read Post »
New Drug ApprovalHibsago (Bepirovirsen) Approved in Japan as First Functional Cure Treatment... Hibsago (Bepirovirsen) Approved in Japan as First Functional Cure Treatment... Read Post »
New Drug ApprovalNICE Recommends Weekly Insulin Efsitora Alfa That Could Cut Injections From... NICE Recommends Weekly Insulin Efsitora Alfa That Could Cut Injections From... Read Post »
New Drug ApprovalFDA Grants PMA to Implantica’s RefluxStop® for GERD Treatment FDA Grants PMA to Implantica’s RefluxStop® for GERD Treatment Read Post »
New Drug ApprovalUltragenyx’s GENGLYCOS Receives FDA Accelerated Approval as First Treatme... Ultragenyx’s GENGLYCOS Receives FDA Accelerated Approval as First Treatme... Read Post »
New Drug ApprovalRegeneron Wins FDA Approval for Pasatru to Reduce New Bone Formation in Adu... Regeneron Wins FDA Approval for Pasatru to Reduce New Bone Formation in Adu... Read Post »
New Drug ApprovalFDA Approves TAUKLARIFY, Expanding Tau PET Imaging for Alzheimer’s Diseas... FDA Approves TAUKLARIFY, Expanding Tau PET Imaging for Alzheimer’s Diseas... Read Post »
New Drug ApprovalBMS’s ZENBEXUS Becomes First FDA-Approved CELMoD for RRMM BMS’s ZENBEXUS Becomes First FDA-Approved CELMoD for RRMM Read Post »
New Drug ApprovalChina Approves Ivonescimab Combination for First-Line Squamous NSCLC China Approves Ivonescimab Combination for First-Line Squamous NSCLC Read Post »
New Drug ApprovalUK Becomes First European Country to Authorise Orforglipron UK Becomes First European Country to Authorise Orforglipron Read Post »
New Drug ApprovalEnhertu® Plus Pertuzumab Approved in China as First-Line Treatment for HER... Enhertu® Plus Pertuzumab Approved in China as First-Line Treatment for HER... Read Post »
New Drug ApprovalChina Approves Yochanra (Tinengotinib) for FGFR Inhibitor-Resistant Cholang... China Approves Yochanra (Tinengotinib) for FGFR Inhibitor-Resistant Cholang... Read Post »
New Drug ApprovalMHRA Authorises Rhapsido (Remibrutinib) for Adults with Chronic Spontaneous... MHRA Authorises Rhapsido (Remibrutinib) for Adults with Chronic Spontaneous... Read Post »
New Drug ApprovalFDA Approves TUDRIQEV: First Oncolytic Viral Immunotherapy for PD-1-Refract... FDA Approves TUDRIQEV: First Oncolytic Viral Immunotherapy for PD-1-Refract... Read Post »
New Drug ApprovalModerna Wins FDA Approval for First mRNA Flu Vaccine mFLUSIVA Moderna Wins FDA Approval for First mRNA Flu Vaccine mFLUSIVA Read Post »
New Drug ApprovalReckitt’s Mucinex 12HR Cold & Fever Multi-Symptom Becomes First F... Reckitt’s Mucinex 12HR Cold & Fever Multi-Symptom Becomes First F... Read Post »
New Drug ApprovalEU Approves Expanded Indication for Sanofi’s MenQuadfi in Infants from Si... EU Approves Expanded Indication for Sanofi’s MenQuadfi in Infants from Si... Read Post »
New Drug ApprovalFresenius Kabi Advances Global Biosimilars Portfolio with FDA, EMA Review o... Fresenius Kabi Advances Global Biosimilars Portfolio with FDA, EMA Review o... Read Post »
New Drug ApprovalFDA Approves Pluvicto® for PSMA-Positive Metastatic Hormone-Sensitive Pros... FDA Approves Pluvicto® for PSMA-Positive Metastatic Hormone-Sensitive Pros... Read Post »
New Drug ApprovalUAE Approves ANKTIVA for Bladder Cancer and Advanced Lung Cancer UAE Approves ANKTIVA for Bladder Cancer and Advanced Lung Cancer Read Post »
New Drug ApprovalEU Approves Datroway for Metastatic Triple-Negative Breast Cancer EU Approves Datroway for Metastatic Triple-Negative Breast Cancer Read Post »
New Drug ApprovalEU Approves Pfizer-BioNTech XFG COVID-19 Vaccine for 2026-2027 EU Approves Pfizer-BioNTech XFG COVID-19 Vaccine for 2026-2027 Read Post »
New Drug ApprovalTeleflex Receives FDA Approval for First Freeze-Dried Plasma Product in the... Teleflex Receives FDA Approval for First Freeze-Dried Plasma Product in the... Read Post »
New Drug ApprovalFDA Approves Viatris’ Gwyn Lo Contraceptive Patch for Pregnancy Preve... FDA Approves Viatris’ Gwyn Lo Contraceptive Patch for Pregnancy Preve... Read Post »
New Drug ApprovalFDA Approves Otsuka’s SIMTRIYO as First Triple Reuptake Inhibitor for... FDA Approves Otsuka’s SIMTRIYO as First Triple Reuptake Inhibitor for... Read Post »
New Drug ApprovalFDA Approves LYTENAVA as First Ophthalmic Bevacizumab for Wet AMD FDA Approves LYTENAVA as First Ophthalmic Bevacizumab for Wet AMD Read Post »
New Drug ApprovalFour CHMP Recommendations Could Reshape Care in Psoriasis, AMD, Asthma, and... Four CHMP Recommendations Could Reshape Care in Psoriasis, AMD, Asthma, and... Read Post »
New Drug ApprovalFDA Approves First Subcutaneous Furosemide Autoinjector for HF and CKD FDA Approves First Subcutaneous Furosemide Autoinjector for HF and CKD Read Post »
New Drug ApprovalAstraZeneca’s Etcamah Wins EU Approval for ESR1-Mutated HR-Positive Advan... AstraZeneca’s Etcamah Wins EU Approval for ESR1-Mutated HR-Positive Advan... Read Post »
New Drug ApprovalChina Approves Takeda’s ORZEYFUL for Narcolepsy Type 1 China Approves Takeda’s ORZEYFUL for Narcolepsy Type 1 Read Post »
New Drug ApprovalFDA Approves GSK’s Jideytro for Previously Treated ROS1-Positive Adva... FDA Approves GSK’s Jideytro for Previously Treated ROS1-Positive Adva... Read Post »
New Drug ApprovalMHRA Approves World’s First Lower-Carbon Beclometasone Inhalers for Asthm... MHRA Approves World’s First Lower-Carbon Beclometasone Inhalers for Asthm... Read Post »
New Drug ApprovalIndia’s First Approved Dengue Vaccine: CDSCO Clears Takeda’s QD... India’s First Approved Dengue Vaccine: CDSCO Clears Takeda’s QD... Read Post »
New Drug ApprovalSystImmune Wins First Global Approval for Iza-bren, the First EGFR×HER3 Bi... SystImmune Wins First Global Approval for Iza-bren, the First EGFR×HER3 Bi... Read Post »
New Drug ApprovalEuropean Commission Approves JASCAYD® (Nerandomilast) for Adults with IPF ... European Commission Approves JASCAYD® (Nerandomilast) for Adults with IPF ... Read Post »
New Drug ApprovalNICE Recommends Finerenone for Chronic Heart Failure with Preserved or Mild... NICE Recommends Finerenone for Chronic Heart Failure with Preserved or Mild... Read Post »
New Drug ApprovalFDA Approves Merck’s LIPFENDRA as First Oral PCSK9 Inhibitor FDA Approves Merck’s LIPFENDRA as First Oral PCSK9 Inhibitor Read Post »
New Drug ApprovalEuropean Commission Approves Wegovy® Pill as First Oral GLP-1 Therapy for ... European Commission Approves Wegovy® Pill as First Oral GLP-1 Therapy for ... Read Post »
New Drug ApprovalFDA Grants Full Approval to Retevmo for RET Fusion-Positive Solid Tumors Ac... FDA Grants Full Approval to Retevmo for RET Fusion-Positive Solid Tumors Ac... Read Post »
