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 »
Clinical TrialsDizal Reports Positive Phase 3 Sunvozertinib Results in NSCLC Dizal Reports Positive Phase 3 Sunvozertinib Results in NSCLC Read Post »
Drugs Safety AlertSeizure Risk Tied to Vitamin B6 Deficiency Prompts FDA Label Changes for Pa... Seizure Risk Tied to Vitamin B6 Deficiency Prompts FDA Label Changes for Pa... 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 »
Clinical TrialsApogee’s Zumilokibart Delivers 52-Week Control in Atopic Dermatitis Trial Apogee’s Zumilokibart Delivers 52-Week Control in Atopic Dermatitis Trial Read Post »
Clinical TrialsFDA Grants Priority Review to Ionis’ Zilganersen for Rare Alexander Disea... FDA Grants Priority Review to Ionis’ Zilganersen for Rare Alexander Disea... Read Post »
Clinical TrialsInsmed’s ARIKAYCE Hits Key Endpoints in Phase 3b ENCORE Trial Insmed’s ARIKAYCE Hits Key Endpoints in Phase 3b ENCORE Trial Read Post »
Clinical TrialsPfizer and Valneva Report >70% Efficacy for Lyme Vaccine Candidate in Phase... Pfizer and Valneva Report >70% Efficacy for Lyme Vaccine Candidate in Phase... Read Post »
Clinical TrialsRoche Stops Emugrobart in SMA and FSHD Trials After Weak Functional Outcome... Roche Stops Emugrobart in SMA and FSHD Trials After Weak Functional Outcome... Read Post »
Clinical TrialsBiohaven Completes Enrollment in Phase 2 Trial of Taldefgrobep for Obesity Biohaven Completes Enrollment in Phase 2 Trial of Taldefgrobep for Obesity Read Post »
Clinical TrialsBiogen-Eisai’s LEQEMBI Shows Strong Real-World Treatment Persistence ... Biogen-Eisai’s LEQEMBI Shows Strong Real-World Treatment Persistence ... Read Post »
Clinical TrialsSerum Institute Taps Eveliqure Platform for Anti-Diarrhoeal Vaccines in Chi... Serum Institute Taps Eveliqure Platform for Anti-Diarrhoeal Vaccines in Chi... 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 »
Clinical TrialsChugai Files in Japan for Ocular Implant Component of Ranibizumab Port Deli... Chugai Files in Japan for Ocular Implant Component of Ranibizumab Port Deli... 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 »
Clinical TrialsPfizer’s TALZENNA Combo Hits rPFS Goal in TALAPRO-3 Pfizer’s TALZENNA Combo Hits rPFS Goal in TALAPRO-3 Read Post »
Drugs Safety AlertEisai Pulls Tazverik in Japan After Global Safety Review Eisai Pulls Tazverik in Japan After Global Safety Review Read Post »
Clinical TrialsSobi Explores Gamifant for Interferon-Gamma–Driven Sepsis in New Phase 2a... Sobi Explores Gamifant for Interferon-Gamma–Driven Sepsis in New Phase 2a... Read Post »
ResearchGrifols Detects Parkinson’s Disease Changes Years Before Diagnosis Grifols Detects Parkinson’s Disease Changes Years Before Diagnosis 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 »
Clinical TrialsRhythm’s EMANATE Misses Endpoint, Highlights Subgroup Benefit Rhythm’s EMANATE Misses Endpoint, Highlights Subgroup Benefit Read Post »
Clinical TrialsPfizer’s Next-Gen CDK4 Inhibitor Shows Phase 2 Breast Cancer Benefit Pfizer’s Next-Gen CDK4 Inhibitor Shows Phase 2 Breast Cancer Benefit Read Post »
Clinical TrialsFDA Finds No Bioequivalence Deficiencies in NRx Preservative-Free Ketamine ... FDA Finds No Bioequivalence Deficiencies in NRx Preservative-Free Ketamine ... Read Post »
Drugs Safety AlertSCFE Cases Prompt BioMarin to Halt Select VOXZOGO Trials in Rare Growth Dis... SCFE Cases Prompt BioMarin to Halt Select VOXZOGO Trials in Rare Growth Dis... Read Post »
Clinical TrialsStructure Therapeutics’ Aleniglipron Demonstrates Strong Weight Loss Structure Therapeutics’ Aleniglipron Demonstrates Strong Weight Loss Read Post »
Clinical TrialsLilly Advances EBGLYSS Pediatric Indication After Positive ADorable-1 Trial... Lilly Advances EBGLYSS Pediatric Indication After Positive ADorable-1 Trial... Read Post »
Clinical TrialsCytomX Eyes Registrational Path for Varseta-M After Encouraging CRC Data CytomX Eyes Registrational Path for Varseta-M After Encouraging CRC Data Read Post »
Clinical TrialsBayer Reports Positive Phase III FIND-CKD Results for Finerenone Bayer Reports Positive Phase III FIND-CKD Results for Finerenone 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 »
Clinical TrialsFDA Allows U.S. Enrollment in BioVersys Phase 3 Trial of BV100 for Drug-Res... FDA Allows U.S. Enrollment in BioVersys Phase 3 Trial of BV100 for Drug-Res... Read Post »
Clinical TrialsNRx Targets FDA Approval for NRX-100 in Severe Depression NRx Targets FDA Approval for NRX-100 in Severe Depression Read Post »
Clinical TrialsAbbott’s Libre CGM Improves HbA1c and Time-in-Range in FreeDM2 Trial Abbott’s Libre CGM Improves HbA1c and Time-in-Range in FreeDM2 Trial 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 »
Clinical TrialsOtsuka’s Repinatrabit Cuts Blood Phe 67% in Adolescents with PKU Otsuka’s Repinatrabit Cuts Blood Phe 67% in Adolescents with PKU Read Post »
Clinical TrialsUnited’s Tyvaso Delivers Positive Phase 3 Results in IPF United’s Tyvaso Delivers Positive Phase 3 Results in IPF Read Post »
Drugs Safety AlertLilly Warns Compounded Tirzepatide Mixed with B12 May Pose Risks Lilly Warns Compounded Tirzepatide Mixed with B12 May Pose Risks Read Post »
Drugs Safety Alert Health TidingsFDA Rolls Out AEMS Safety Dashboard, Saving $120M FDA Rolls Out AEMS Safety Dashboard, Saving $120M 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 »
Clinical TrialsCapricor Reports New HOPE-3 Data Showing Deramiocel Improves Cardiac and Fu... Capricor Reports New HOPE-3 Data Showing Deramiocel Improves Cardiac and Fu... Read Post »
Clinical TrialsBridgeBio Unveils Strong Phase 3 Interim Data for BBP-418 in LGMD2I/R9 at M... BridgeBio Unveils Strong Phase 3 Interim Data for BBP-418 in LGMD2I/R9 at M... Read Post »
Clinical TrialsBioMarin Presents New VOXZOGO Data Supporting Early Treatment in Achondropl... BioMarin Presents New VOXZOGO Data Supporting Early Treatment in Achondropl... Read Post »
Clinical TrialsBiogen Initiates Phase 3 Program for Salanersen Following Promising Phase 1... Biogen Initiates Phase 3 Program for Salanersen Following Promising Phase 1... 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 »
Clinical TrialsAscletis’ GLP-1 ASC30 Depot Injection Achieves Promising Phase 2 Results ... Ascletis’ GLP-1 ASC30 Depot Injection Achieves Promising Phase 2 Results ... Read Post »
