New Drug ApprovalFDA Expands ANKTIVA Approval to High-Grade Papillary-Only Bladder Cancer FDA Expands ANKTIVA Approval to High-Grade Papillary-Only Bladder Cancer Read Post »
New Drug ApprovalFDA Approves HOVILPRI for Refractory HSV Lesions in Immunocompromised Adult... FDA Approves HOVILPRI for Refractory HSV Lesions in Immunocompromised Adult... Read Post »
New Drug ApprovalFDA Approves Tecentriq Plus Chemotherapy for Stage III dMMR Colon Cancer FDA Approves Tecentriq Plus Chemotherapy for Stage III dMMR Colon Cancer Read Post »
New Drug ApprovalTeva Wins FDA Approval for WELTRUZA in Schizophrenia Teva Wins FDA Approval for WELTRUZA in Schizophrenia Read Post »
New Drug ApprovalFDA Approves Rhapsido as First Treatment for Symptomatic Dermographism FDA Approves Rhapsido as First Treatment for Symptomatic Dermographism Read Post »
New Drug ApprovalFDA Approves TUKYSA as First-Line Maintenance in Breast Cancer FDA Approves TUKYSA as First-Line Maintenance in Breast Cancer Read Post »
New Drug ApprovalJaypirca FDA Approval Expands Pirtobrutinib Use in CLL/SLL Jaypirca FDA Approval Expands Pirtobrutinib Use in CLL/SLL Read Post »
New Drug ApprovalFDA Approves Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome in Pat... FDA Approves Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome in Pat... Read Post »
New Drug ApprovalFDA Approves EMCITATE® (tiratricol), First Treatment for MCT8 Deficiency FDA Approves EMCITATE® (tiratricol), First Treatment for MCT8 Deficiency Read Post »
New Drug ApprovalFDA Approves WELIREG Plus LENVIMA for Advanced ccRCC FDA Approves WELIREG Plus LENVIMA for Advanced ccRCC Read Post »
New Drug ApprovalAbbVie’s Jumvo (Tavapadon) Receives FDA Approval for Parkinson’s Diseas... AbbVie’s Jumvo (Tavapadon) Receives FDA Approval for Parkinson’s Diseas... Read Post »
New Drug ApprovalFDA Approves Atebrioz (zilurgisertib) for FOP Treatment FDA Approves Atebrioz (zilurgisertib) for FOP Treatment Read Post »
New Drug ApprovalFDA Expands Olumiant Approval to Adolescents with Severe Alopecia Areata FDA Expands Olumiant Approval to Adolescents with Severe Alopecia Areata Read Post »
New Drug ApprovalFDA Approves Belzutifan Plus Lenvatinib for Advanced RCC With a Clear Cell ... FDA Approves Belzutifan Plus Lenvatinib for Advanced RCC With a Clear Cell ... Read Post »
New Drug ApprovalLilly Wins FDA Approval for Once-Weekly Basal Insulin Onswik in Type 2 Diab... Lilly Wins FDA Approval for Once-Weekly Basal Insulin Onswik in Type 2 Diab... Read Post »
New Drug ApprovalFDA Approves Lyrfigtu for FGFR2-Positive Cholangiocarcinoma FDA Approves Lyrfigtu for FGFR2-Positive Cholangiocarcinoma Read Post »
New Drug ApprovalRINVOQ Gains EU Approval for Pediatric Polyarticular JIA RINVOQ Gains EU Approval for Pediatric Polyarticular JIA Read Post »
New Drug ApprovalRoche Susvimo Wins EU Approval for Neovascular AMD Roche Susvimo Wins EU Approval for Neovascular AMD Read Post »
New Drug ApprovalFDA Grants Full Approval to Inluriyo Plus Verzenio for ESR1-Mutated Advance... FDA Grants Full Approval to Inluriyo Plus Verzenio for ESR1-Mutated Advance... Read Post »
New Drug ApprovalFDA Approves Aqneursa for Ataxia in Patients with Ataxia-Telangiectasia FDA Approves Aqneursa for Ataxia in Patients with Ataxia-Telangiectasia Read Post »
New Drug ApprovalSogroya Gets Positive EU Opinion for Idiopathic Short Stature Sogroya Gets Positive EU Opinion for Idiopathic Short Stature Read Post »
New Drug ApprovalFDA Approves FAYUVI for Sanfilippo Syndrome Type A FDA Approves FAYUVI for Sanfilippo Syndrome Type A Read Post »
New Drug ApprovalFDA Approves Kerendia for Type 1 Diabetes-Associated CKD FDA Approves Kerendia for Type 1 Diabetes-Associated CKD Read Post »
New Drug ApprovalFDA Approves Curium’s BEXLUTRY as First Radioligand Equivalent to LUTATHE... FDA Approves Curium’s BEXLUTRY as First Radioligand Equivalent to LUTATHE... Read Post »
New Drug ApprovalFDA Approves Ameluz PDT for Superficial Basal Cell Carcinoma FDA Approves Ameluz PDT for Superficial Basal Cell Carcinoma Read Post »
New Drug ApprovalFDA Approves Pixclara as First FET-PET Imaging Drug for Glioma FDA Approves Pixclara as First FET-PET Imaging Drug for Glioma Read Post »
New Drug ApprovalPharming Wins FDA Approval to Expand Joenja to Children With APDS Pharming Wins FDA Approval to Expand Joenja to Children With APDS Read Post »
New Drug ApprovalFDA Approves ISEMBYLD as First Muscle-Targeted Therapy for Spinal Muscular ... FDA Approves ISEMBYLD as First Muscle-Targeted Therapy for Spinal Muscular ... Read Post »
Disease & Drugs New Drug ApprovalFDA Expands Sevabertinib Approval to First-Line HER2-Mutant NSCLC FDA Expands Sevabertinib Approval to First-Line HER2-Mutant NSCLC Read Post »
New Drug ApprovalAstraZeneca Camizestrant Wins FDA Approval in ESR1 Breast Cancer AstraZeneca Camizestrant Wins FDA Approval in ESR1 Breast Cancer Read Post »
New Drug ApprovalFDA Approves First Treatment for Alexander Disease, Bringing New Hope to Pa... FDA Approves First Treatment for Alexander Disease, Bringing New Hope to Pa... Read Post »
New Drug ApprovalEnhertu Plus Pertuzumab Wins EU Approval After Strong Phase III Results Enhertu Plus Pertuzumab Wins EU Approval After Strong Phase III Results Read Post »
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 »
