Clinical TrialsAriBio’s AR1005 Improves Cognitive Fluctuations in Interim Phase 2a D... AriBio’s AR1005 Improves Cognitive Fluctuations in Interim Phase 2a D... Read Post »
Health TidingsCaliway Advances CBL-514 With FDA-Cleared Tirzepatide Trial and Phase 3 Enr... Caliway Advances CBL-514 With FDA-Cleared Tirzepatide Trial and Phase 3 Enr... Read Post »
New Drug ApprovalFDA Approves Tivicay PD for HIV-1 Treatment in Babies from Birth FDA Approves Tivicay PD for HIV-1 Treatment in Babies from Birth Read Post »
Health TidingsAstellas Advances ASP2138 Into Phase 3 Development for HER2-Negative Gastri... Astellas Advances ASP2138 Into Phase 3 Development for HER2-Negative Gastri... Read Post »
Clinical TrialsApollo Therapeutics Reports Positive Part A Immunogenicity Data for Pan-Rhi... Apollo Therapeutics Reports Positive Part A Immunogenicity Data for Pan-Rhi... Read Post »
New Drug ApprovalZiihera Plus Tislelizumab Approved for HER2-Positive GEA Without PD-L1 Requ... Ziihera Plus Tislelizumab Approved for HER2-Positive GEA Without PD-L1 Requ... Read Post »
Clinical TrialsLong-Term Real-World Data Show Sustained Disease Stabilization with Arimocl... Long-Term Real-World Data Show Sustained Disease Stabilization with Arimocl... Read Post »
Clinical TrialsRezpegaldesleukin Delivers Positive Phase 2b Results in Atopic Dermatitis, ... Rezpegaldesleukin Delivers Positive Phase 2b Results in Atopic Dermatitis, ... Read Post »
Health Tidings Mergers & AcquisitionsMcKesson to Acquire Precision Medicine Group for $2.25 Billion, Expanding C... McKesson to Acquire Precision Medicine Group for $2.25 Billion, Expanding C... Read Post »
Clinical TrialsIvonescimab Plus Chemotherapy Extends Progression-Free Survival After Third... Ivonescimab Plus Chemotherapy Extends Progression-Free Survival After Third... Read Post »
Health TidingsCDSCO Expert Committee Recommends Bioequivalence and Phase III Trial Waiver... CDSCO Expert Committee Recommends Bioequivalence and Phase III Trial Waiver... Read Post »
New Drug ApprovalGC Green Cross Secures Hunterase Approvals for Hunter Syndrome in India and... GC Green Cross Secures Hunterase Approvals for Hunter Syndrome in India and... Read Post »
New Drug ApprovalORZEYFUL Approved in Japan as First and Only Medicine to Treat the Underlyi... ORZEYFUL Approved in Japan as First and Only Medicine to Treat the Underlyi... Read Post »
Clinical TrialsInotuzumab Ozogamicin Shows 71% Response Rate in Children with Very High-Ri... Inotuzumab Ozogamicin Shows 71% Response Rate in Children with Very High-Ri... Read Post »
Clinical TrialsNovel Four-Drug Combination Shows Robust Activity Against Metastatic PDAC Novel Four-Drug Combination Shows Robust Activity Against Metastatic PDAC Read Post »
ResearchNRG5051 Targets mPTP Through Novel NLRX1 Mechanism in ALS NRG5051 Targets mPTP Through Novel NLRX1 Mechanism in ALS Read Post »
New Drug ApprovalFDA Approves IMAAVY® (nipocalimab-aahu) as the First Approved Treatment fo... FDA Approves IMAAVY® (nipocalimab-aahu) as the First Approved Treatment fo... Read Post »
Health TidingsErasca Granted FDA Fast Track Designation for ERAS-0015 in Metastatic Pancr... Erasca Granted FDA Fast Track Designation for ERAS-0015 in Metastatic Pancr... Read Post »
Health TidingsLEQEMBI IQLIK® (lecanemab-irmb) Autoinjector for Initiation and Maintenanc... LEQEMBI IQLIK® (lecanemab-irmb) Autoinjector for Initiation and Maintenanc... Read Post »
Clinical TrialsFDA Places Clinical Hold on REGENXBIO’s RGX-121 After Spine MRI Findings ... FDA Places Clinical Hold on REGENXBIO’s RGX-121 After Spine MRI Findings ... Read Post »
Health TidingsFDA Extends Deramiocel Review to November 2026 as Capricor Refines DMD Indi... FDA Extends Deramiocel Review to November 2026 as Capricor Refines DMD Indi... Read Post »
Health TidingsFDA Accepts United’s NDA for Ralinepag in Pulmonary Arterial Hypertension FDA Accepts United’s NDA for Ralinepag in Pulmonary Arterial Hypertension Read Post »
Clinical TrialsTrastuzumab Rezetecan Extends Progression-Free Survival to 30.6 Months in H... Trastuzumab Rezetecan Extends Progression-Free Survival to 30.6 Months in H... Read Post »
Health TidingsFDA Accepts Jemperli (Dostarlimab) for Priority Review in dMMR/MSI-H Locall... FDA Accepts Jemperli (Dostarlimab) for Priority Review in dMMR/MSI-H Locall... Read Post »
Health Tidings Mergers & AcquisitionsHanmi Pharm Signs Up to $2.3 Billion Genentech Deal for Obesity Candidate H... Hanmi Pharm Signs Up to $2.3 Billion Genentech Deal for Obesity Candidate H... Read Post »
New Drug ApprovalHibsago (Bepirovirsen) Approved in Japan as First Functional Cure Treatment... Hibsago (Bepirovirsen) Approved in Japan as First Functional Cure Treatment... Read Post »
Clinical TrialsMazdutide Produces Up to 18.1% Weight Loss in US Phase 2 Obesity Trial Mazdutide Produces Up to 18.1% Weight Loss in US Phase 2 Obesity Trial Read Post »
New Drug ApprovalNICE Recommends Weekly Insulin Efsitora Alfa That Could Cut Injections From... NICE Recommends Weekly Insulin Efsitora Alfa That Could Cut Injections From... Read Post »
Health TidingsSenju Advances SJP-0049 Into Phase III Trial in Japan for Allergic Conjunct... Senju Advances SJP-0049 Into Phase III Trial in Japan for Allergic Conjunct... Read Post »
GenericsZydus Secures USFDA Approval for Ascorbic Acid Injection for Scurvy Zydus Secures USFDA Approval for Ascorbic Acid Injection for Scurvy Read Post »
Clinical TrialsBelzutifan-Lenvatinib Improves Progression-Free Survival in Previously Trea... Belzutifan-Lenvatinib Improves Progression-Free Survival in Previously Trea... Read Post »
ResearchOrganoids Are Reshaping Drug Development as Research Moves from Animal Stud... Organoids Are Reshaping Drug Development as Research Moves from Animal Stud... Read Post »
ResearchSafety of Experimental Gene and Cell Therapies Under Scrutiny: What Recent ... Safety of Experimental Gene and Cell Therapies Under Scrutiny: What Recent ... Read Post »
Health Tidings Mergers & AcquisitionsWerewolf Therapeutics and Ambros Therapeutics Merge to Advance Neridronate ... Werewolf Therapeutics and Ambros Therapeutics Merge to Advance Neridronate ... Read Post »
Health TidingsGossamer Secures Up to $250 Million to Advance Seralutinib Toward FDA Revie... Gossamer Secures Up to $250 Million to Advance Seralutinib Toward FDA Revie... Read Post »
Health TidingsMilestone Advances Etripamil into Phase 3 Trial for Acute AFib With Rapid V... Milestone Advances Etripamil into Phase 3 Trial for Acute AFib With Rapid V... Read Post »
Clinical TrialsCefixime Adds No Benefit to Azithromycin in Large Typhoid Trial, Reinforcin... Cefixime Adds No Benefit to Azithromycin in Large Typhoid Trial, Reinforcin... Read Post »
New Drug ApprovalFDA Grants PMA to Implantica’s RefluxStop® for GERD Treatment FDA Grants PMA to Implantica’s RefluxStop® for GERD Treatment Read Post »
Health TidingsNIH Awards $6.5 Million Grant to Advance Phase 3 PP-01 Trial in Cannabis Us... NIH Awards $6.5 Million Grant to Advance Phase 3 PP-01 Trial in Cannabis Us... Read Post »
Clinical TrialsZalfermin Fails to Add Fibrosis Benefit to Semaglutide in Phase 2 MASH Tria... Zalfermin Fails to Add Fibrosis Benefit to Semaglutide in Phase 2 MASH Tria... Read Post »
Clinical TrialsMepolizumab Improves Disease Control and Moves Patients Toward Remission in... Mepolizumab Improves Disease Control and Moves Patients Toward Remission in... Read Post »
Health TidingsRein Therapeutics Receives FDA Fast Track Designation for LTI-03 in Idiopat... Rein Therapeutics Receives FDA Fast Track Designation for LTI-03 in Idiopat... Read Post »
Health Tidings Mergers & AcquisitionsChai Discovery and Bristol Myers Squibb Partner to Advance AI-Driven Antibo... Chai Discovery and Bristol Myers Squibb Partner to Advance AI-Driven Antibo... Read Post »
Clinical TrialsCan Lower-Dose Aspirin Reduce Cancer Risk in People With Lynch Syndrome? Ca... Can Lower-Dose Aspirin Reduce Cancer Risk in People With Lynch Syndrome? Ca... Read Post »
Health TidingsNuvation Bio’s Safusidenib Receives FDA Fast Track Designation in IDH1-Mu... Nuvation Bio’s Safusidenib Receives FDA Fast Track Designation in IDH1-Mu... Read Post »
Health Tidings Mergers & AcquisitionsTolerance Bio Advances Efineptakin Alfa into Phase 2 Development for Thymic... Tolerance Bio Advances Efineptakin Alfa into Phase 2 Development for Thymic... Read Post »
Health TidingsFDA Details Clinical Evidence Supporting ASCENIV Expansion to Children Aged... FDA Details Clinical Evidence Supporting ASCENIV Expansion to Children Aged... Read Post »
Clinical TrialsPositive Phase 1 Findings Put AC Immune’s Brain-Penetrant NLRP3 Inhib... Positive Phase 1 Findings Put AC Immune’s Brain-Penetrant NLRP3 Inhib... Read Post »
Clinical TrialsLeads Biolabs’ LBL-024 (Opamtistomig) Shows 65% Response Rate in First-Li... Leads Biolabs’ LBL-024 (Opamtistomig) Shows 65% Response Rate in First-Li... Read Post »
GenericsGlenmark Wins U.S. FDA Approval for Fluticasone Propionate Nasal Spray Glenmark Wins U.S. FDA Approval for Fluticasone Propionate Nasal Spray Read Post »
