Health TidingsFDA Lifts Clinical Hold on Filana’s Simufilam IND for TSC-Related Epileps... FDA Lifts Clinical Hold on Filana’s Simufilam IND for TSC-Related Epileps... Read Post »
Health Tidings Mergers & AcquisitionsLexeo Expands Friedreich Ataxia Pipeline With Mantle Acquisition Lexeo Expands Friedreich Ataxia Pipeline With Mantle Acquisition Read Post »
Health Tidings Mergers & AcquisitionsEnvisagenics, Boehringer Partner on RNA Splicing Cancer Targets Envisagenics, Boehringer Partner on RNA Splicing Cancer Targets Read Post »
Health TidingsFDA Recommends Overall Survival Trial Prior to BLA Submission for Tovecimig... FDA Recommends Overall Survival Trial Prior to BLA Submission for Tovecimig... Read Post »
Health TidingsIvonescimab Beats Durvalumab on OS in Phase III Trial Ivonescimab Beats Durvalumab on OS in Phase III Trial Read Post »
Health TidingsPharming’s Leniolisib Shows Encouraging Results in Phase II PID Trial Pharming’s Leniolisib Shows Encouraging Results in Phase II PID Trial Read Post »
Health Tidings Mergers & AcquisitionsAbbVie and Iambic Partner to Accelerate AI-Driven Small-Molecule Drug Disco... AbbVie and Iambic Partner to Accelerate AI-Driven Small-Molecule Drug Disco... Read Post »
Health Tidings Mergers & AcquisitionsTelix to Acquire ITM in $1.65 Billion Radiopharmaceutical Deal Telix to Acquire ITM in $1.65 Billion Radiopharmaceutical Deal Read Post »
Health TidingsAP02 Shows Higher Lung Exposure with Favorable Safety in IPF AP02 Shows Higher Lung Exposure with Favorable Safety in IPF Read Post »
Health TidingsCoiled Completes Enrolment in Two New AO-252 Formulation Cohorts Coiled Completes Enrolment in Two New AO-252 Formulation Cohorts Read Post »
Health TidingsFDA Accepts ARIKAYCE sNDA for Full Approval in MAC Lung Disease with Priori... FDA Accepts ARIKAYCE sNDA for Full Approval in MAC Lung Disease with Priori... Read Post »
Health TidingsPureTech’s LYT-200 Advances to Phase 2 in High-Risk MDS With FDA Fast Tra... PureTech’s LYT-200 Advances to Phase 2 in High-Risk MDS With FDA Fast Tra... Read Post »
Health TidingsBeacon’s Laru-Zova Meets Primary LLVA Endpoint in X-Linked Retinitis Pigm... Beacon’s Laru-Zova Meets Primary LLVA Endpoint in X-Linked Retinitis Pigm... Read Post »
Health TidingsOtsuka’s Centanafadine New Data Shows Core ADHD and Anxiety Benefits Otsuka’s Centanafadine New Data Shows Core ADHD and Anxiety Benefits Read Post »
Health TidingsCUE-221 Shows Durable Results in Phase 2 CSU Trial CUE-221 Shows Durable Results in Phase 2 CSU Trial Read Post »
Health TidingsCHMP Recommends Relacorilant for Ovarian Cancer CHMP Recommends Relacorilant for Ovarian Cancer Read Post »
Health TidingsKlygefa Recommended for EU Approval in AChR-Positive Generalised Myasthenia... Klygefa Recommended for EU Approval in AChR-Positive Generalised Myasthenia... Read Post »
Health TidingsFDA Grants Priority Review to Efzimfotase Alfa BLA for Hypophosphatasia FDA Grants Priority Review to Efzimfotase Alfa BLA for Hypophosphatasia Read Post »
Health TidingsDersimelagon Gets FDA Priority Review for EPP and XLP Dersimelagon Gets FDA Priority Review for EPP and XLP Read Post »
Health TidingsEMA Maintains Negative Opinion on MaaT013 in Acute Graft-versus-Host Diseas... EMA Maintains Negative Opinion on MaaT013 in Acute Graft-versus-Host Diseas... Read Post »
Health TidingsAltis Labs Raises $25M to Advance AI Endpoints in Oncology Altis Labs Raises $25M to Advance AI Endpoints in Oncology Read Post »
Health TidingsXenon Submits Azetukalner NDA for Focal Seizures; Pauses Psychiatry Trial E... Xenon Submits Azetukalner NDA for Focal Seizures; Pauses Psychiatry Trial E... Read Post »
Health Tidings Mergers & AcquisitionsRoche, Dualitas Launch Bispecific Antibody Discovery Deal Roche, Dualitas Launch Bispecific Antibody Discovery Deal Read Post »
Health Tidings Mergers & AcquisitionsLisata Acquires Marea, Raises $225M for Cardioendocrine Drug Development Lisata Acquires Marea, Raises $225M for Cardioendocrine Drug Development Read Post »
Health TidingsAquestive Resubmits Anaphylm NDA to FDA After Positive Human Factors and PK... Aquestive Resubmits Anaphylm NDA to FDA After Positive Human Factors and PK... Read Post »
Health TidingsFDA Updates IBTROZI Label With 49.7-Month DOR in ROS1+ NSCLC FDA Updates IBTROZI Label With 49.7-Month DOR in ROS1+ NSCLC Read Post »
Health TidingsNICE Recommends Enhertu for Routine NHS Use in HER2-Low Advanced Breast Can... NICE Recommends Enhertu for Routine NHS Use in HER2-Low Advanced Breast Can... Read Post »
Health TidingsSironax Brain Delivery Platform Acquired by Novartis Sironax Brain Delivery Platform Acquired by Novartis Read Post »
Health TidingsFDA Grants Fast Track Designation to Cesalatamig for PD-(L)1-Refractory NSC... FDA Grants Fast Track Designation to Cesalatamig for PD-(L)1-Refractory NSC... Read Post »
Health Tidings Mergers & AcquisitionsNovo Nordisk and Anthropic Partner to Accelerate AI-Driven Drug Discovery Novo Nordisk and Anthropic Partner to Accelerate AI-Driven Drug Discovery Read Post »
Health TidingsGilead Expands Lenacapavir Licenses to Support Potential Once-Yearly HIV Pr... Gilead Expands Lenacapavir Licenses to Support Potential Once-Yearly HIV Pr... Read Post »
Health TidingsBexicaserin Advances to Phase III DEEp SEA Trial With Completion of Randomi... Bexicaserin Advances to Phase III DEEp SEA Trial With Completion of Randomi... Read Post »
Health TidingsSionna Shifts Focus to Proprietary CFTR Combination Following Phase 2a SION... Sionna Shifts Focus to Proprietary CFTR Combination Following Phase 2a SION... Read Post »
Health TidingsSling Secures $123M to Advance Oral Linsitinib in Phase 3 Thyroid Eye Disea... Sling Secures $123M to Advance Oral Linsitinib in Phase 3 Thyroid Eye Disea... Read Post »
Health Tidings Mergers & AcquisitionsGSK to Acquire Chimagen’s Trispecific T-Cell Engager for Multiple Myeloma GSK to Acquire Chimagen’s Trispecific T-Cell Engager for Multiple Myeloma Read Post »
Health TidingsFDA Accepts Bezuclastinib NDA for Advanced Systemic Mastocytosis FDA Accepts Bezuclastinib NDA for Advanced Systemic Mastocytosis Read Post »
Health TidingsImvax Advances IGV-001 Toward Phase 3 After FDA Alignment in High-Risk Glio... Imvax Advances IGV-001 Toward Phase 3 After FDA Alignment in High-Risk Glio... Read Post »
Health TidingsArrowhead ARO-DIMER-PA Cuts PCSK9 72% and APOC3 88% Arrowhead ARO-DIMER-PA Cuts PCSK9 72% and APOC3 88% Read Post »
Health TidingsBioVie’s Bezisterim Shows Promise in Long COVID Patients with High Sympto... BioVie’s Bezisterim Shows Promise in Long COVID Patients with High Sympto... Read Post »
Health TidingsBH-30643 Shows 45% Response Rate in EGFR C797S NSCLC BH-30643 Shows 45% Response Rate in EGFR C797S NSCLC Read Post »
Health TidingsPerspective Adds Keytruda to Phase 1/2a Trial of FAP-Targeted Alpha Therapy... Perspective Adds Keytruda to Phase 1/2a Trial of FAP-Targeted Alpha Therapy... Read Post »
Health TidingsFDA Grants RASONQUE Breakthrough Therapy Designation for First-Line PDAC FDA Grants RASONQUE Breakthrough Therapy Designation for First-Line PDAC Read Post »
Health TidingsBeta Bionics Mint Patch Pump Wins FDA Clearance Beta Bionics Mint Patch Pump Wins FDA Clearance Read Post »
Health TidingsFDA Shortens Initial IMDELLTRA Monitoring for Patients With ES-SCLC FDA Shortens Initial IMDELLTRA Monitoring for Patients With ES-SCLC Read Post »
Health TidingsDefinium’s DT120 ODT Delivers Positive Phase 3 Results in GAD Definium’s DT120 ODT Delivers Positive Phase 3 Results in GAD Read Post »
Health TidingsTakeda Zasocitinib Gets FDA Priority Review for Psoriasis Takeda Zasocitinib Gets FDA Priority Review for Psoriasis Read Post »
Health TidingsAstraZeneca’s Tagrisso Improves Long-Term Survival in Early-Stage EGFR-Mu... AstraZeneca’s Tagrisso Improves Long-Term Survival in Early-Stage EGFR-Mu... Read Post »
Health TidingsGotistobart Extends Median Survival to 18.5 Months in Previously Treated Sq... Gotistobart Extends Median Survival to 18.5 Months in Previously Treated Sq... Read Post »
Health TidingsJ&J’s Amivantamab Plus Chemotherapy Delivers 34.3-Month Median Overal... J&J’s Amivantamab Plus Chemotherapy Delivers 34.3-Month Median Overal... Read Post »
Health TidingsFDA Extends Review of Zanzalintinib Combination in Metastatic Colorectal Ca... FDA Extends Review of Zanzalintinib Combination in Metastatic Colorectal Ca... Read Post »
