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 »
Health TidingsFDA Requests Rat PK Data Before DiaMedica’s DM199 IND in Preeclampsia FDA Requests Rat PK Data Before DiaMedica’s DM199 IND in Preeclampsia Read Post »
Clinical TrialsJazz Highlights New Xywav Data Showing Cardiometabolic Benefits and Persona... Jazz Highlights New Xywav Data Showing Cardiometabolic Benefits and Persona... Read Post »
Health TidingsFDA Accepts Resubmitted LYTENAVA BLA for Wet AMD FDA Accepts Resubmitted LYTENAVA BLA for Wet AMD Read Post »
Health TidingsZai Lab Wins EMA Orphan Drug Designation for DLL3-Targeting ADC Zoci Zai Lab Wins EMA Orphan Drug Designation for DLL3-Targeting ADC Zoci 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 »
Lifestyle WellnessTorii-Verrica Advance Wart Therapy in Global Phase 3 Program Torii-Verrica Advance Wart Therapy in Global Phase 3 Program Read Post »
Clinical TrialsRhythm Highlights Long-Term Setmelanotide and Bivamelagon Data Across Rare ... Rhythm Highlights Long-Term Setmelanotide and Bivamelagon Data Across Rare ... Read Post »
Health TidingsMHRA and FDA Embed Regulatory Staff Across Atlantic to Advance Collaboratio... MHRA and FDA Embed Regulatory Staff Across Atlantic to Advance Collaboratio... Read Post »
Health TidingsBelite Bio Files FDA NDA for Tinlarebant in Stargardt Disease Belite Bio Files FDA NDA for Tinlarebant in Stargardt Disease Read Post »
Health TidingsAlkermes Wins U.S. and EU Orphan Drug Designations for Alixorexton Alkermes Wins U.S. and EU Orphan Drug Designations for Alixorexton Read Post »
Health TidingsElicio Narrows Phase 3 Focus for ELI-002 After Pancreatic Cancer Trial Reve... Elicio Narrows Phase 3 Focus for ELI-002 After Pancreatic Cancer Trial Reve... Read Post »
Clinical TrialsVYKAT XR Shows Durable Hyperphagia and Behavioral Benefits in PWS VYKAT XR Shows Durable Hyperphagia and Behavioral Benefits in PWS Read Post »
Health TidingsFDA Accepts Inhibrx’s Ozekibart BLA for Advanced Chondrosarcoma FDA Accepts Inhibrx’s Ozekibart BLA for Advanced Chondrosarcoma Read Post »
Health TidingsFDA Begins Review of Weekly Oral Yeztugo for HIV Prevention FDA Begins Review of Weekly Oral Yeztugo for HIV Prevention Read Post »
Clinical TrialsOveporexton Improves Daily Functioning and Sleep in Narcolepsy Type 1 Oveporexton Improves Daily Functioning and Sleep in Narcolepsy Type 1 Read Post »
Clinical TrialsNeurocrine Highlights Broad Long-Term Benefits of CRENESSITY Across Adult, ... Neurocrine Highlights Broad Long-Term Benefits of CRENESSITY Across Adult, ... Read Post »
Health TidingsNeumora Ends Navacaprant Program After Two Phase 3 Depression Trial Failure... Neumora Ends Navacaprant Program After Two Phase 3 Depression Trial Failure... Read Post »
