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 »
Clinical TrialsfrontMIND Trial Meets Primary Endpoint in High-Risk DLBCL and HGBL frontMIND Trial Meets Primary Endpoint in High-Risk DLBCL and HGBL Read Post »
Health TidingsFDA Approves First PTEN Companion Diagnostic for TRUQAP in Prostate Cancer FDA Approves First PTEN Companion Diagnostic for TRUQAP in Prostate Cancer Read Post »
Medical DevicesFirst Over-the-Counter CGM Wins FDA Approval for Pediatric Use First Over-the-Counter CGM Wins FDA Approval for Pediatric Use Read Post »
Health TidingsFDA Grants Accelerated Approval to Tzield for Children with Stage 3 T1D FDA Grants Accelerated Approval to Tzield for Children with Stage 3 T1D Read Post »
Health TidingsFDA Approves Truqap for PTEN-Deficient Metastatic Prostate Cancer FDA Approves Truqap for PTEN-Deficient Metastatic Prostate Cancer Read Post »
New Drug ApprovalFDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... FDA Approves New KEYTRUDA-WELIREG Regimen to Prevent Kidney Cancer Recurren... Read Post »
New Drug ApprovalUK Approves Europe’s First Oral Wegovy for Weight Management UK Approves Europe’s First Oral Wegovy for Weight Management Read Post »
New Drug ApprovalAkeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Akeso Secures NMPA Approval for Gumokimab in Moderate-to-Severe Plaque Psor... Read Post »
Drugs Safety AlertPRAC Finds Inconsistent Evidence on Paternal Valproate Risk in Children PRAC Finds Inconsistent Evidence on Paternal Valproate Risk in Children Read Post »
Mergers & AcquisitionsRichter and Hetero Team Up on Generic Semaglutide for Global Markets Richter and Hetero Team Up on Generic Semaglutide for Global Markets Read Post »
Health TidingsBeOne Reports Strong Tacabrutideg and ZS Outcomes in CLL, MCL, and WM BeOne Reports Strong Tacabrutideg and ZS Outcomes in CLL, MCL, and WM Read Post »
Health TidingsBioCryst Reports Long-Term ORLADEYO Benefits and New Navenibart Data in HAE BioCryst Reports Long-Term ORLADEYO Benefits and New Navenibart Data in HAE Read Post »
Clinical TrialsNovartis’ Rhapsido Delivers Positive Phase 3 Results in CIU Novartis’ Rhapsido Delivers Positive Phase 3 Results in CIU Read Post »
Clinical TrialsCogent Advances Bezuclastinib Toward NDA Submission With Positive APEX Resu... Cogent Advances Bezuclastinib Toward NDA Submission With Positive APEX Resu... Read Post »
Clinical TrialsJazz’s Phase 3 LAGOON Trial Fails to Improve Survival in Relapsed SCL... Jazz’s Phase 3 LAGOON Trial Fails to Improve Survival in Relapsed SCL... Read Post »
Lifestyle WellnessGalderma Survey Shows Long-Lasting Results Drive Anti-Wrinkle Treatment Dec... Galderma Survey Shows Long-Lasting Results Drive Anti-Wrinkle Treatment Dec... Read Post »
Clinical TrialsVenetoclax Plus Obinutuzumab Cuts Risk of Progression or Death by 50% in CL... Venetoclax Plus Obinutuzumab Cuts Risk of Progression or Death by 50% in CL... Read Post »
Health TidingsGSK Secures Orphan Drug Designations in US and EU for Momelotinib in VEXAS ... GSK Secures Orphan Drug Designations in US and EU for Momelotinib in VEXAS ... Read Post »
