Health TidingsIMUNON Reports Positive Safety Review for Phase 3 IMNN-001 Ovarian Cancer S... IMUNON Reports Positive Safety Review for Phase 3 IMNN-001 Ovarian Cancer S... Read Post »
Health Tidings Mergers & AcquisitionsInsilico and SK Biopharmaceuticals Pursue New Neuroimmune Treatments Using ... Insilico and SK Biopharmaceuticals Pursue New Neuroimmune Treatments Using ... Read Post »
Health TidingsFDA Rejects Cytisinicline NDA for Now, Requests Manufacturing Resolution FDA Rejects Cytisinicline NDA for Now, Requests Manufacturing Resolution Read Post »
Health TidingsFDA Grants Rolling Review for QTORIN Rapamycin NDA in Rare Lymphatic Malfor... FDA Grants Rolling Review for QTORIN Rapamycin NDA in Rare Lymphatic Malfor... Read Post »
Health TidingsFDA Clears EAP for NRX-101 to Enhance TMS in Treatment-Resistant Depression FDA Clears EAP for NRX-101 to Enhance TMS in Treatment-Resistant Depression Read Post »
Health TidingsMedicus Showcases SkinJect and Teverelix Development Progress at BIO Intern... Medicus Showcases SkinJect and Teverelix Development Progress at BIO Intern... Read Post »
Health TidingsFDA Grants Breakthrough Status to Elsunersen After Strong Seizure Reduction... FDA Grants Breakthrough Status to Elsunersen After Strong Seizure Reduction... Read Post »
Health Tidings Mergers & AcquisitionsAbbVie to Acquire Apogee Therapeutics for $10.9B, Expanding Immunology and ... AbbVie to Acquire Apogee Therapeutics for $10.9B, Expanding Immunology and ... Read Post »
Health TidingsRegeneron Secures FDA Priority Review for Cemdisiran in gMG Regeneron Secures FDA Priority Review for Cemdisiran in gMG Read Post »
Health TidingsREGENXBIO Advances NAVSUNLI Toward Accelerated FDA Approval REGENXBIO Advances NAVSUNLI Toward Accelerated FDA Approval Read Post »
Health TidingsFDA Seeks Major Label Updates for Testosterone Therapy Following Review of ... FDA Seeks Major Label Updates for Testosterone Therapy Following Review of ... Read Post »
GenericsFDA Grants Tentative Approval to Alembic’s Generic Binimetinib FDA Grants Tentative Approval to Alembic’s Generic Binimetinib Read Post »
Health TidingsKither’s KIT2014 Advances as a Potential Dual-Action Therapy for Mult... Kither’s KIT2014 Advances as a Potential Dual-Action Therapy for Mult... Read Post »
Health TidingsChugai Files New Drug Application in Japan for Sparsentan in IgA Nephropath... Chugai Files New Drug Application in Japan for Sparsentan in IgA Nephropath... Read Post »
Health TidingsSanofi Wins Japan Approval for Subcutaneous Sarclisa in Multiple Myeloma Sanofi Wins Japan Approval for Subcutaneous Sarclisa in Multiple Myeloma 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 »
Generics Mergers & AcquisitionsSamsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCH... Samsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCH... 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 »
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 »
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 »
GenericsFDA Approves First Generic Xofluza for Influenza Treatment and Prevention FDA Approves First Generic Xofluza for Influenza Treatment and Prevention 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 »
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 »
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 »
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 »
