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 »
New Drug ApprovalFDA Approves REVTORPYK for PIK3CA Wild-Type HR+/HER2- Advanced Breast Cance... FDA Approves REVTORPYK for PIK3CA Wild-Type HR+/HER2- Advanced Breast Cance... Read Post »
New Drug ApprovalFDA Approves Weekly LEQEMBI IQLIK Autoinjector for At-Home Initiation of Ea... FDA Approves Weekly LEQEMBI IQLIK Autoinjector for At-Home Initiation of Ea... Read Post »
New Drug ApprovalFDA Approves Merck’s Keytruda Plus Pfizer-Astellas’ Padcev for ... FDA Approves Merck’s Keytruda Plus Pfizer-Astellas’ Padcev for ... Read Post »
New Drug ApprovalSanofi Wins US FDA Approval for Subcutaneous Sarclisa Escena, First Cancer ... Sanofi Wins US FDA Approval for Subcutaneous Sarclisa Escena, First Cancer ... Read Post »
New Drug ApprovalMHRA Approves Nerandomilast for Idiopathic Pulmonary Fibrosis and Progressi... MHRA Approves Nerandomilast for Idiopathic Pulmonary Fibrosis and Progressi... Read Post »
New Drug ApprovalFDA Grants Accelerated Approval to TRUTAKNA for IgA Nephropathy FDA Grants Accelerated Approval to TRUTAKNA for IgA Nephropathy Read Post »
New Drug ApprovalFDA Expands WILATE Prophylaxis Approval to Children Under 6 With von Willeb... FDA Expands WILATE Prophylaxis Approval to Children Under 6 With von Willeb... Read Post »
New Drug ApprovalEU Approves TEPKINLY Plus R2 as New Chemotherapy-Free Option for Follicular... EU Approves TEPKINLY Plus R2 as New Chemotherapy-Free Option for Follicular... Read Post »
New Drug ApprovalMHRA Approves Incyte’s Retifanlimab for Advanced Merkel Cell Carcinom... MHRA Approves Incyte’s Retifanlimab for Advanced Merkel Cell Carcinom... Read Post »
New Drug ApprovalMHRA Conditionally Approves Wegovy for MASH MHRA Conditionally Approves Wegovy for MASH Read Post »
New Drug ApprovalMHRA Authorises Inqlexzo Gemcitabine Delivery System for BCG-Unresponsive H... MHRA Authorises Inqlexzo Gemcitabine Delivery System for BCG-Unresponsive H... Read Post »
New Drug ApprovalEU Approves Novartis’ Itvisma as First Gene Replacement Therapy for C... EU Approves Novartis’ Itvisma as First Gene Replacement Therapy for C... Read Post »
New Drug ApprovalHUTCHMED Secures Third Approved Indication in China for ORPATHYS HUTCHMED Secures Third Approved Indication in China for ORPATHYS Read Post »
New Drug ApprovalFDA Approves CASGEVY for Children Aged 2 and Older With SCD and TDT FDA Approves CASGEVY for Children Aged 2 and Older With SCD and TDT Read Post »
New Drug ApprovalFDA Expands ZORYVE Cream Approval to Children as Young as 2 Years with Plaq... FDA Expands ZORYVE Cream Approval to Children as Young as 2 Years with Plaq... Read Post »
New Drug ApprovalEU Approves Enhertu as First HER2 Tumor-Agnostic Therapy for Advanced Solid... EU Approves Enhertu as First HER2 Tumor-Agnostic Therapy for Advanced Solid... Read Post »
New Drug ApprovalFDA Approves Veligrotug as First Treatment for Active and Chronic Thyroid E... FDA Approves Veligrotug as First Treatment for Active and Chronic Thyroid E... Read Post »
New Drug ApprovalFDA Approves SKYRIZI for Children with Plaque Psoriasis and Psoriatic Arthr... FDA Approves SKYRIZI for Children with Plaque Psoriasis and Psoriatic Arthr... Read Post »
New Drug ApprovalFDA Approves KEYTRUDA Plus Trodelvy for First-Line Advanced Triple-Negative... FDA Approves KEYTRUDA Plus Trodelvy for First-Line Advanced Triple-Negative... Read Post »
New Drug ApprovalTrodelvy Wins FDA Approval for First-Line mTNBC After EU Approval Trodelvy Wins FDA Approval for First-Line mTNBC After EU Approval Read Post »
New Drug ApprovalFDA Approves IBRANCE for HR+/HER2+ Metastatic Breast Cancer FDA Approves IBRANCE for HR+/HER2+ Metastatic Breast Cancer Read Post »
New Drug ApprovalFDA Approves TRYNGOLZA (Olezarsen) to Reduce Triglycerides and Acute Pancre... FDA Approves TRYNGOLZA (Olezarsen) to Reduce Triglycerides and Acute Pancre... Read Post »
New Drug ApprovalPADCEV Plus Keytruda Wins EU Approval for Cisplatin-Ineligible MIBC PADCEV Plus Keytruda Wins EU Approval for Cisplatin-Ineligible MIBC Read Post »
New Drug ApprovalSanofi’s Wayrilz Wins Japan Approval for Chronic Immune Thrombocytopenia Sanofi’s Wayrilz Wins Japan Approval for Chronic Immune Thrombocytopenia Read Post »
New Drug ApprovalEU Authorizes MAVIRET for Adults and Children with Acute Hepatitis C EU Authorizes MAVIRET for Adults and Children with Acute Hepatitis C Read Post »
New Drug ApprovalSanofi Wins EU Approval for Cenrifki in Non-Relapsing SPMS Sanofi Wins EU Approval for Cenrifki in Non-Relapsing SPMS Read Post »
New Drug ApprovalJapan Expands Xocova Approval to Children Aged 6–11 Years With COVID-19 Japan Expands Xocova Approval to Children Aged 6–11 Years With COVID-19 Read Post »
New Drug ApprovalJapan Approves Avastin as First-Ever Therapy for Neurofibromatosis Type 2 Japan Approves Avastin as First-Ever Therapy for Neurofibromatosis Type 2 Read Post »
New Drug ApprovalJapan Approves Minjuvi Plus Lenalidomide for Relapsed or Refractory DLBCL Japan Approves Minjuvi Plus Lenalidomide for Relapsed or Refractory DLBCL Read Post »
New Drug ApprovalFDA Expands CAPVAXIVE Approval for Children and Adolescents at Increased Pn... FDA Expands CAPVAXIVE Approval for Children and Adolescents at Increased Pn... Read Post »
New Drug ApprovalUtebzi (Tebipenem Pivoxil) Receives FDA Approval for Adults with cUTI Utebzi (Tebipenem Pivoxil) Receives FDA Approval for Adults with cUTI Read Post »
Lifestyle New Drug Approval WellnessAbbVie Secures FDA Approval for SKINVIVE in Horizontal Neck Wrinkles AbbVie Secures FDA Approval for SKINVIVE in Horizontal Neck Wrinkles Read Post »
New Drug ApprovalFDA Approves Amphastar’s Rextovy OTC Naloxone Spray FDA Approves Amphastar’s Rextovy OTC Naloxone Spray Read Post »
New Drug ApprovalFDA Approves Low-Gadolinium MRI Contrast Agent AMBELVIST FDA Approves Low-Gadolinium MRI Contrast Agent AMBELVIST Read Post »
New Drug ApprovalChina Approves Vanflyta for Newly Diagnosed FLT3-ITD Positive AML China Approves Vanflyta for Newly Diagnosed FLT3-ITD Positive AML Read Post »
New Drug ApprovalFDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... FDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... Read Post »
New Drug ApprovalUK Approves Europe’s First Oral Wegovy for Weight Management UK Approves Europe’s First Oral Wegovy for Weight Management Read Post »
New Drug ApprovalAkeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Akeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Read Post »
New Drug ApprovalFDA Expands Organon’s TOFIDENCE Biosimilar Approval to CAR-T CRS and COVI... FDA Expands Organon’s TOFIDENCE Biosimilar Approval to CAR-T CRS and COVI... Read Post »
New Drug ApprovalFDA Approves Every-8-Week EBGLYSS Dosing for Atopic Dermatitis FDA Approves Every-8-Week EBGLYSS Dosing for Atopic Dermatitis Read Post »
New Drug ApprovalFDA Adds Bemotrizinol to OTC Sunscreen Monograph, First New UV Filter in Ov... FDA Adds Bemotrizinol to OTC Sunscreen Monograph, First New UV Filter in Ov... Read Post »
New Drug ApprovalMHRA Grants Authorization for Nipocalimab in gMG MHRA Grants Authorization for Nipocalimab in gMG Read Post »
New Drug ApprovalEU Approves Sarclisa On-Body Injector Option for Multiple Myeloma EU Approves Sarclisa On-Body Injector Option for Multiple Myeloma Read Post »
New Drug ApprovalFDA Approves HYMPAVZI for Children and Hemophilia Patients With Inhibitors FDA Approves HYMPAVZI for Children and Hemophilia Patients With Inhibitors Read Post »
New Drug ApprovalNMPA Approves Lupeng’s Rocbrutinib, China’s First Fourth-Generation... NMPA Approves Lupeng’s Rocbrutinib, China’s First Fourth-Generation... Read Post »
