Clinical TrialsCorxel Reports Positive Results for Oral GLP-1 CX11 in Obesity Corxel Reports Positive Results for Oral GLP-1 CX11 in Obesity Read Post »
Clinical TrialsTScan Reports Strong Phase 1 Results for TSC-101 Ahead of Phase 3 Trial TScan Reports Strong Phase 1 Results for TSC-101 Ahead of Phase 3 Trial Read Post »
Health Tidings Mergers & AcquisitionsInsilico and SK Biopharmaceuticals Pursue New Neuroimmune Treatments Using ... Insilico and SK Biopharmaceuticals Pursue New Neuroimmune Treatments Using ... 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 »
Clinical TrialsPP-01 Advances Toward Becoming First Approved Treatment for Cannabis Withdr... PP-01 Advances Toward Becoming First Approved Treatment for Cannabis Withdr... Read Post »
Clinical TrialsExelixis Reports Positive Final STELLAR-303 Survival Data in Metastatic Col... Exelixis Reports Positive Final STELLAR-303 Survival Data in Metastatic Col... Read Post »
Health TidingsFDA Rejects Cytisinicline NDA for Now, Requests Manufacturing Resolution FDA Rejects Cytisinicline NDA for Now, Requests Manufacturing Resolution Read Post »
Clinical TrialsFDA Grants Priority Review for Tivicay PD to Treat HIV in Newborns from Bir... FDA Grants Priority Review for Tivicay PD to Treat HIV in Newborns from Bir... Read Post »
Clinical TrialsPfizer’s Sigvotatug Vedotin Misses Overall Survival Endpoint in Phase 3 N... Pfizer’s Sigvotatug Vedotin Misses Overall Survival Endpoint in Phase 3 N... Read Post »
Health TidingsFDA Grants Rolling Review for QTORIN Rapamycin NDA in Rare Lymphatic Malfor... FDA Grants Rolling Review for QTORIN Rapamycin NDA in Rare Lymphatic Malfor... Read Post »
Health TidingsFDA Clears EAP for NRX-101 to Enhance TMS in Treatment-Resistant Depression FDA Clears EAP for NRX-101 to Enhance TMS in Treatment-Resistant Depression Read Post »
Health TidingsMedicus Showcases SkinJect and Teverelix Development Progress at BIO Intern... Medicus Showcases SkinJect and Teverelix Development Progress at BIO Intern... Read Post »
Clinical TrialsDefinium’s DT120 Succeeds in Phase 3 Trial for Major Depression Definium’s DT120 Succeeds in Phase 3 Trial for Major Depression Read Post »
Clinical TrialsBoehringer Advances Late-Stage Oncology Pipeline with Three Global Phase II... Boehringer Advances Late-Stage Oncology Pipeline with Three Global Phase II... Read Post »
Clinical TrialsMerck’s Tulisokibart Shows Strong Phase 3 Efficacy in Ulcerative Colitis Merck’s Tulisokibart Shows Strong Phase 3 Efficacy in Ulcerative Colitis Read Post »
Health TidingsFDA Grants Breakthrough Status to Elsunersen After Strong Seizure Reduction... FDA Grants Breakthrough Status to Elsunersen After Strong Seizure Reduction... Read Post »
Health Tidings Mergers & AcquisitionsAbbVie to Acquire Apogee Therapeutics for $10.9B, Expanding Immunology and ... AbbVie to Acquire Apogee Therapeutics for $10.9B, Expanding Immunology and ... Read Post »
Health TidingsRegeneron Secures FDA Priority Review for Cemdisiran in gMG Regeneron Secures FDA Priority Review for Cemdisiran in gMG Read Post »
Health TidingsREGENXBIO Advances NAVSUNLI Toward Accelerated FDA Approval REGENXBIO Advances NAVSUNLI Toward Accelerated FDA Approval Read Post »
Health TidingsFDA Seeks Major Label Updates for Testosterone Therapy Following Review of ... FDA Seeks Major Label Updates for Testosterone Therapy Following Review of ... Read Post »
Clinical TrialsCynata’s Pivotal aGvHD and Osteoarthritis Trials Miss Primary Endpoints Cynata’s Pivotal aGvHD and Osteoarthritis Trials Miss Primary Endpoints Read Post »
Clinical TrialsInnovent Advances IBI3003 into Phase 3 Testing for Multiple Myeloma Innovent Advances IBI3003 into Phase 3 Testing for Multiple Myeloma Read Post »
Clinical TrialsMoonLake Reports Strong One-Year Phase 3 Results for Sonelokimab in Hidrade... MoonLake Reports Strong One-Year Phase 3 Results for Sonelokimab in Hidrade... Read Post »
GenericsFDA Grants Tentative Approval to Alembic’s Generic Binimetinib FDA Grants Tentative Approval to Alembic’s Generic Binimetinib Read Post »
Clinical TrialsRezolute Presents New Ersodetug Analyses Following Mixed Phase 3 Results Rezolute Presents New Ersodetug Analyses Following Mixed Phase 3 Results Read Post »
Clinical TrialsSuven’s Ropanicant Improves Depression Scores in Phase 2b Trial Suven’s Ropanicant Improves Depression Scores in Phase 2b Trial 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 »
Clinical TrialsSuven’s SUVN-I6107 Shows Early Cognitive Benefits and CNS Activity in Pha... Suven’s SUVN-I6107 Shows Early Cognitive Benefits and CNS Activity in Pha... Read Post »
Health TidingsKither’s KIT2014 Advances as a Potential Dual-Action Therapy for Mult... Kither’s KIT2014 Advances as a Potential Dual-Action Therapy for Mult... Read Post »
Health TidingsChugai Files New Drug Application in Japan for Sparsentan in IgA Nephropath... Chugai Files New Drug Application in Japan for Sparsentan in IgA Nephropath... Read Post »
Health TidingsSanofi Wins Japan Approval for Subcutaneous Sarclisa in Multiple Myeloma Sanofi Wins Japan Approval for Subcutaneous Sarclisa in Multiple Myeloma Read Post »
Clinical TrialsJohnson & Johnson Reports Positive MEMBRANE Trial Results Demonstrating... Johnson & Johnson Reports Positive MEMBRANE Trial Results Demonstrating... Read Post »
Clinical TrialsuniQure Reports Positive Data for AMT-260 in Drug-Resistant Epilepsy uniQure Reports Positive Data for AMT-260 in Drug-Resistant Epilepsy 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 »
Health TidingsTeva Submits FDA Application for Ecopipam in Pediatric Tourette Syndrome Teva Submits FDA Application for Ecopipam in Pediatric Tourette Syndrome Read Post »
Health TidingsFDA Panel Votes 9-0 in Support of Moderna’s mRNA Flu Vaccine FDA Panel Votes 9-0 in Support of Moderna’s mRNA Flu Vaccine Read Post »
Clinical TrialsFDA Clears IND for CSPC’s Monthly Octreotide in U.S. Acromegaly Trial FDA Clears IND for CSPC’s Monthly Octreotide in U.S. Acromegaly Trial Read Post »
Clinical TrialsEnanta Advances Zelicapavir into Registrational RSV Trial Enanta Advances Zelicapavir into Registrational RSV Trial Read Post »
Generics Mergers & AcquisitionsSamsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCH... Samsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCH... Read Post »
Clinical TrialsEdgewise Reports Positive Phase 2 CIRRUS-HCM Results for EDG-7500 Edgewise Reports Positive Phase 2 CIRRUS-HCM Results for EDG-7500 Read Post »
Health TidingsZabopegdutide Demonstrates Robust Fibrosis Reduction in MASH Trial Zabopegdutide Demonstrates Robust Fibrosis Reduction in MASH Trial Read Post »
Health Tidings Mergers & AcquisitionsVoro and Alloy Partner to Develop Safer T-Cell Engager Therapies Voro and Alloy Partner to Develop Safer T-Cell Engager Therapies Read Post »
Health TidingsNovocure’s Phase 3 TRIDENT Trial Misses Survival Endpoint in Glioblastoma... Novocure’s Phase 3 TRIDENT Trial Misses Survival Endpoint in Glioblastoma... Read Post »
Clinical TrialsProJenX Reports Positive Data for First-in-Class CNS-Penetrant Prosetin in ... ProJenX Reports Positive Data for First-in-Class CNS-Penetrant Prosetin in ... Read Post »
Clinical TrialsAlkermes Reports Positive Results for Alixorexton in Narcolepsy Type 2 Alkermes Reports Positive Results for Alixorexton in Narcolepsy Type 2 Read Post »
Clinical TrialsNerandomilast Extends Projected Survival by Up to 5.4 Years in IPF Nerandomilast Extends Projected Survival by Up to 5.4 Years in IPF Read Post »
Health TidingsFDA Accepts Lunsumio VELO Plus Polivy Application After Strong Phase 3 SUNM... FDA Accepts Lunsumio VELO Plus Polivy Application After Strong Phase 3 SUNM... Read Post »
Clinical TrialsShionogi and F2G Report Positive Phase 3 Results for Olorofim in Invasive A... Shionogi and F2G Report Positive Phase 3 Results for Olorofim in Invasive A... 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 »
