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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
Health TidingsCaliway’s CBL-514 Cuts Weight Regain When Added to Tirzepatide in Pre... Caliway’s CBL-514 Cuts Weight Regain When Added to Tirzepatide in Pre... Read Post »
Health TidingsNovartis Reports Positive FORTITUDE Data for Del-Brax in FSHD Novartis Reports Positive FORTITUDE Data for Del-Brax in FSHD Read Post »
Health TidingsTakeda Reports Phase 3 Win for Zasocitinib in Plaque Psoriasis Takeda Reports Phase 3 Win for Zasocitinib in Plaque Psoriasis Read Post »
Health TidingsCASGEVY Extends Durable Clinical Benefit to Children With SCD and TDT CASGEVY Extends Durable Clinical Benefit to Children With SCD and TDT Read Post »
Health TidingsCemsidomide Achieves 53% Response Rate in Phase 1/2 Multiple Myeloma Trial Cemsidomide Achieves 53% Response Rate in Phase 1/2 Multiple Myeloma Trial Read Post »
Health TidingsFDA Delays CAM2029 Approval in Acromegaly Over Manufacturing Issues FDA Delays CAM2029 Approval in Acromegaly Over Manufacturing Issues Read Post »
Health TidingsFDA Grants Priority Review to Roche’s Tecentriq in Early-Stage Colon Canc... FDA Grants Priority Review to Roche’s Tecentriq in Early-Stage Colon Canc... Read Post »
Health Tidings Mergers & AcquisitionsServier, n-Lorem Launch ASO Research Partnership in Rare Neurology Servier, n-Lorem Launch ASO Research Partnership in Rare Neurology Read Post »
Health Tidings Mergers & AcquisitionsNovartis Expands Orionis Partnership in $1.4 Billion Molecular Glue Drug Di... Novartis Expands Orionis Partnership in $1.4 Billion Molecular Glue Drug Di... Read Post »
Health TidingsOno Files VELEXBRU Expansion in Japan for Secondary CNS Lymphoma Ono Files VELEXBRU Expansion in Japan for Secondary CNS Lymphoma Read Post »
Health TidingsWhat Zepbound and Shaquille O’Neal’s Story Reveal About Undiagn... What Zepbound and Shaquille O’Neal’s Story Reveal About Undiagn... Read Post »
Health TidingsEMA Begins Review of Bayer’s Asundexian for Secondary Stroke Prevention EMA Begins Review of Bayer’s Asundexian for Secondary Stroke Prevention Read Post »
Health TidingsFDA Accepts Takeda’s ENTYVIO sBLA for Pediatric Ulcerative Colitis and Cr... FDA Accepts Takeda’s ENTYVIO sBLA for Pediatric Ulcerative Colitis and Cr... Read Post »
Health TidingsBausch Health Secures Key Reimbursement Milestone for PrOKEDI in Canada Bausch Health Secures Key Reimbursement Milestone for PrOKEDI in Canada Read Post »
Health Tidings Mergers & AcquisitionsLilly Signs Potential $1 Billion Alzheimer’s Deal With AlzeCure Lilly Signs Potential $1 Billion Alzheimer’s Deal With AlzeCure Read Post »
Health TidingsTeva Presents New AUSTEDO Data Across the Tardive Dyskinesia Care Continuum Teva Presents New AUSTEDO Data Across the Tardive Dyskinesia Care Continuum Read Post »
Health TidingsNMPA Approves TIVDAK for Recurrent or Metastatic Cervical Cancer NMPA Approves TIVDAK for Recurrent or Metastatic Cervical Cancer Read Post »
Health Tidings Mergers & AcquisitionsGSK Acquires Nuvalent, Adding FDA-Reviewed ROS1 and ALK Inhibitors GSK Acquires Nuvalent, Adding FDA-Reviewed ROS1 and ALK Inhibitors Read Post »
Health TidingsMerck and Gilead Halt Phase 3 KEYNOTE-D46/EVOKE-03 Study Over Missing PFS E... Merck and Gilead Halt Phase 3 KEYNOTE-D46/EVOKE-03 Study Over Missing PFS E... Read Post »
Health TidingsUK Clears Moderna’s mRNA-4194 for Lynch Syndrome Cancer Prevention Study UK Clears Moderna’s mRNA-4194 for Lynch Syndrome Cancer Prevention Study Read Post »
Health Tidings Mergers & AcquisitionsRoche Licenses Nurix’s BTK Degrader Bexobrutideg in Up to $2.3 Billion De... Roche Licenses Nurix’s BTK Degrader Bexobrutideg in Up to $2.3 Billion De... Read Post »
Health Tidings Mergers & AcquisitionsIncyte Bolsters Hematology Growth With $2 Billion Vega Buyout Incyte Bolsters Hematology Growth With $2 Billion Vega Buyout Read Post »
Health TidingsKorlym Cuts HbA1c and Weight in Difficult-to-Control Diabetes Linked to Hyp... Korlym Cuts HbA1c and Weight in Difficult-to-Control Diabetes Linked to Hyp... Read Post »
Health TidingsFDA Review Accepted for Alvotech’s Vedolizumab Biosimilar FDA Review Accepted for Alvotech’s Vedolizumab Biosimilar Read Post »
Health TidingsMazdutide Achieves 18.6% Weight Loss in Adults With Obesity Mazdutide Achieves 18.6% Weight Loss in Adults With Obesity Read Post »
Health TidingsFoundayo Shows Consistent Weight Loss Across Menopause Stages in Phase 3 AT... Foundayo Shows Consistent Weight Loss Across Menopause Stages in Phase 3 AT... Read Post »
