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 »
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 »
