Health TidingsBausch Advances Dual-Action Dry Eye Drop to Phase 3 Despite Missing Phase 2... Bausch Advances Dual-Action Dry Eye Drop to Phase 3 Despite Missing Phase 2... Read Post »
Clinical TrialsSpyre’s SPY072 Shows Efficacy Signals in Rheumatoid Arthritis, but Falls ... Spyre’s SPY072 Shows Efficacy Signals in Rheumatoid Arthritis, but Falls ... Read Post »
Clinical TrialsCan a New Cell-Based Transplant Repair Severe Eye Damage from Aniridia-Rela... Can a New Cell-Based Transplant Repair Severe Eye Damage from Aniridia-Rela... Read Post »
New Drug ApprovalRevolution Medicines’ RASONQUE (Daraxonrasib) Becomes First Approved RAS(... Revolution Medicines’ RASONQUE (Daraxonrasib) Becomes First Approved RAS(... Read Post »
Clinical TrialsTRB-061 Shows Treg Activation and Expansion in Phase 1a Study, Supporting A... TRB-061 Shows Treg Activation and Expansion in Phase 1a Study, Supporting A... Read Post »
Clinical TrialsCelcuity Submits sNDA to FDA for REVTORPYK in PIK3CA-Mutant Advanced Breast... Celcuity Submits sNDA to FDA for REVTORPYK in PIK3CA-Mutant Advanced Breast... Read Post »
Health TidingsMahzi Therapeutics Announces FDA Rare Pediatric Disease Designation for MZ-... Mahzi Therapeutics Announces FDA Rare Pediatric Disease Designation for MZ-... Read Post »
Clinical TrialsNeurocrine Gets FDA Clearance for Phase 2 NBI-1117567 Alzheimer’s Study Neurocrine Gets FDA Clearance for Phase 2 NBI-1117567 Alzheimer’s Study Read Post »
Health TidingsAirway Therapeutics Raises $50 Million to Advance Zelpultide Alfa in Bronch... Airway Therapeutics Raises $50 Million to Advance Zelpultide Alfa in Bronch... Read Post »
Health TidingsAbbott’s Libre Duo 10 Day Receives FDA Authorization for Continuous G... Abbott’s Libre Duo 10 Day Receives FDA Authorization for Continuous G... Read Post »
Health TidingsPeptron Advances PT403 Into Phase 1 Development as Once-Monthly Semaglutide... Peptron Advances PT403 Into Phase 1 Development as Once-Monthly Semaglutide... Read Post »
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 »
