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 »
Clinical TrialsHumacyte’s ATEV Improves Dialysis Access and Reduces Infections in Women Humacyte’s ATEV Improves Dialysis Access and Reduces Infections in Women 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 »
Health Tidings Mergers & AcquisitionsBiogen to Acquire RayThera in Up to $1 Billion Deal, Expanding Immunology P... Biogen to Acquire RayThera in Up to $1 Billion Deal, Expanding Immunology P... Read Post »
Clinical TrialsBrain Communications Data Show KYGEVVI Reduces Death Risk by Up to 94% in E... Brain Communications Data Show KYGEVVI Reduces Death Risk by Up to 94% in E... Read Post »
GenericsFDA Approves First Generic Xofluza for Influenza Treatment and Prevention FDA Approves First Generic Xofluza for Influenza Treatment and Prevention Read Post »
Clinical TrialsMIRA Submits Phase 2a Trial Protocol for Ketamir-2 in CIPN MIRA Submits Phase 2a Trial Protocol for Ketamir-2 in CIPN Read Post »
Health TidingsOcular Aligns with FDA on AXPAXLI NDA Submission for Wet AMD, Targets Filin... Ocular Aligns with FDA on AXPAXLI NDA Submission for Wet AMD, Targets Filin... Read Post »
Mergers & AcquisitionsJazz and AbCellera Partner to Develop T-Cell Engagers for GI and Solid Tumo... Jazz and AbCellera Partner to Develop T-Cell Engagers for GI and Solid Tumo... Read Post »
Clinical TrialsBioMarin Reports Long-Term VOXZOGO Growth Benefits in Hypochondroplasia, Ad... BioMarin Reports Long-Term VOXZOGO Growth Benefits in Hypochondroplasia, Ad... Read Post »
Health TidingsFDA Grants Orphan Status to Sernova’s Cell Pouch in Post-Pancreatecto... FDA Grants Orphan Status to Sernova’s Cell Pouch in Post-Pancreatecto... Read Post »
Clinical TrialsSedana Medical Files NDA for Isoflurane ICU Sedation System Sedana Medical Files NDA for Isoflurane ICU Sedation System Read Post »
Clinical TrialsFDA Agrees AMT-130 Data Can Support Huntington’s Disease BLA FDA Agrees AMT-130 Data Can Support Huntington’s Disease BLA Read Post »
Health TidingsFDA Grants Fast Track Status to NovaBridge’s Givastomig FDA Grants Fast Track Status to NovaBridge’s Givastomig Read Post »
Health TidingsModerna Targets New Vaccine, Oncology, and Rare Disease Launches Through 20... Moderna Targets New Vaccine, Oncology, and Rare Disease Launches Through 20... Read Post »
