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 »
Health TidingsFDA Accepts New Cenobamate Formulation for Adults With Focal Seizures FDA Accepts New Cenobamate Formulation for Adults With Focal Seizures Read Post »
New Drug ApprovalFDA Approves Low-Gadolinium MRI Contrast Agent AMBELVIST FDA Approves Low-Gadolinium MRI Contrast Agent AMBELVIST Read Post »
Clinical TrialsAnti-ACTH Antibody Asedebart Shows Strong Cortisol Control in Cushing’s D... Anti-ACTH Antibody Asedebart Shows Strong Cortisol Control in Cushing’s D... Read Post »
Clinical TrialsLegend Biotech Reports First-in-Human Proof-of-Concept for In Vivo CAR-T Cl... Legend Biotech Reports First-in-Human Proof-of-Concept for In Vivo CAR-T Cl... Read Post »
Health TidingsFDA Grants Priority Review to Ultomiris for IgA Nephropathy FDA Grants Priority Review to Ultomiris for IgA Nephropathy Read Post »
Health TidingsEpcoritamab Delivers Durable First-Line Responses in Elderly DLBCL Patients Epcoritamab Delivers Durable First-Line Responses in Elderly DLBCL Patients Read Post »
New Drug ApprovalChina Approves Vanflyta for Newly Diagnosed FLT3-ITD Positive AML China Approves Vanflyta for Newly Diagnosed FLT3-ITD Positive AML Read Post »
Health TidingsLilly’s First-in-Class Type II JAK2 Inhibitor Delivers Strong Early R... Lilly’s First-in-Class Type II JAK2 Inhibitor Delivers Strong Early R... Read Post »
Clinical TrialsIncyte’s INCA033989 Delivers Durable Responses in CALR-Mutated MPNs at EH... Incyte’s INCA033989 Delivers Durable Responses in CALR-Mutated MPNs at EH... Read Post »
Clinical TrialsZilurgisertib Cuts New Bone Formation in FOP, FDA Grants Priority Review Zilurgisertib Cuts New Bone Formation in FOP, FDA Grants Priority Review Read Post »
Clinical TrialsJaypirca Regimen Cuts Progression Risk by 45% in Relapsed CLL Jaypirca Regimen Cuts Progression Risk by 45% in Relapsed CLL Read Post »
Clinical TrialsSun Pharma’s UNLOXCYT™ Delivers Durable Responses in Advanced CSCC Sun Pharma’s UNLOXCYT™ Delivers Durable Responses in Advanced CSCC Read Post »
Health TidingsMHRA Clears Lower-Dose EURneffy for Children at Risk of Anaphylaxis MHRA Clears Lower-Dose EURneffy for Children at Risk of Anaphylaxis Read Post »
Health TidingsTalquetamab Regimens Deliver Strong Survival Gains in Relapsed Myeloma Talquetamab Regimens Deliver Strong Survival Gains in Relapsed Myeloma Read Post »
Health TidingsLonvo-z Demonstrates Significant Attack Reduction in Hereditary Angioedema Lonvo-z Demonstrates Significant Attack Reduction in Hereditary Angioedema Read Post »
Clinical TrialsSetmelanotide Lowers BMI and Improves Hyperphagia in Prader-Willi Syndrome Setmelanotide Lowers BMI and Improves Hyperphagia in Prader-Willi Syndrome Read Post »
Clinical TrialsAgios Presents Phase 3 RISE UP Results for Mitapivat in Sickle Cell Disease... Agios Presents Phase 3 RISE UP Results for Mitapivat in Sickle Cell Disease... Read Post »
