Clinical Trials Mergers & AcquisitionsAmplia and Lilly Partner to Advance Narmafotinib Plus Olomorasib for KRAS G... Amplia and Lilly Partner to Advance Narmafotinib Plus Olomorasib for KRAS G... Read Post »
Clinical TrialsAravax Secures FDA Fast Track Designation for PVX108 in Peanut Allergy Aravax Secures FDA Fast Track Designation for PVX108 in Peanut Allergy Read Post »
New Drug ApprovalFresenius Kabi Advances Global Biosimilars Portfolio with FDA, EMA Review o... Fresenius Kabi Advances Global Biosimilars Portfolio with FDA, EMA Review o... Read Post »
Health TidingsAcurx Advances Ibezapolstat Toward Phase 3 Following Positive FDA Feedback Acurx Advances Ibezapolstat Toward Phase 3 Following Positive FDA Feedback Read Post »
Health TidingsFDA Supports Oculis’ Privosegtor for Acute Multiple Sclerosis Relapse... FDA Supports Oculis’ Privosegtor for Acute Multiple Sclerosis Relapse... Read Post »
GenericsFDA Approves Garzulys Biosimilar to NovoLog for Adults and Children with Di... FDA Approves Garzulys Biosimilar to NovoLog for Adults and Children with Di... Read Post »
Clinical Trials Disease & DrugsCan-Fite Launches Phase 2 Clinical Program of Piclidenoson for Rare Genetic... Can-Fite Launches Phase 2 Clinical Program of Piclidenoson for Rare Genetic... Read Post »
Clinical TrialsReal-World Study Supports Long-Term Safety of Arimoclomol in Niemann-Pick D... Real-World Study Supports Long-Term Safety of Arimoclomol in Niemann-Pick D... Read Post »
Health TidingsGefurulimab PREVAIL Trial Shows Benefit in Generalized Myasthenia Gravis Gefurulimab PREVAIL Trial Shows Benefit in Generalized Myasthenia Gravis Read Post »
Health TidingsLilly Secures FDA Breakthrough Therapy Designation for Olomorasib in KRAS G... Lilly Secures FDA Breakthrough Therapy Designation for Olomorasib in KRAS G... Read Post »
Clinical TrialsCAPRISA 012C Trial Reveals Viral Resistance as Key Challenge for Broadly Ne... CAPRISA 012C Trial Reveals Viral Resistance as Key Challenge for Broadly Ne... Read Post »
Clinical TrialsRocket Reports Favorable Early Safety in RP-A501 Trial for Danon Disease Rocket Reports Favorable Early Safety in RP-A501 Trial for Danon Disease Read Post »
Health TidingsZai Lab’s DLL3 ADC Zocilurtatug Pelitecan Receives FDA Orphan Drug Design... Zai Lab’s DLL3 ADC Zocilurtatug Pelitecan Receives FDA Orphan Drug Design... Read Post »
ResearchA Wave of RMAT Designations: What FDA’s Latest Decisions Mean for Reg... A Wave of RMAT Designations: What FDA’s Latest Decisions Mean for Reg... Read Post »
New Drug ApprovalFDA Approves Pluvicto® for PSMA-Positive Metastatic Hormone-Sensitive Pros... FDA Approves Pluvicto® for PSMA-Positive Metastatic Hormone-Sensitive Pros... Read Post »
Health TidingsEvommune Advances Novel MRGPRX2 Therapy to Phase 2b for Migraine Evommune Advances Novel MRGPRX2 Therapy to Phase 2b for Migraine Read Post »
New Drug ApprovalUAE Approves ANKTIVA for Bladder Cancer and Advanced Lung Cancer UAE Approves ANKTIVA for Bladder Cancer and Advanced Lung Cancer Read Post »
Health TidingsOtsuka Study Suggests S-Equol May Help Women With Severe PMS and PMDD Otsuka Study Suggests S-Equol May Help Women With Severe PMS and PMDD Read Post »
Health TidingsNovel Oral HIV Capsid Inhibitor VH-499 Reduces Viral Load in Phase 2a Study Novel Oral HIV Capsid Inhibitor VH-499 Reduces Viral Load in Phase 2a Study Read Post »
Health TidingsTiziana Reports Third Phase 2 MSA Patient Shows Reduced Neuroinflammation o... Tiziana Reports Third Phase 2 MSA Patient Shows Reduced Neuroinflammation o... Read Post »
Clinical TrialsAnnamycin Maintains Blinded Remission Rates in Difficult-to-Treat AML Patie... Annamycin Maintains Blinded Remission Rates in Difficult-to-Treat AML Patie... Read Post »
Clinical TrialsZiltivekimab Fails to Reduce Cardiovascular Events in Phase III ZEUS Trial Ziltivekimab Fails to Reduce Cardiovascular Events in Phase III ZEUS Trial Read Post »
New Drug ApprovalEU Approves Datroway for Metastatic Triple-Negative Breast Cancer EU Approves Datroway for Metastatic Triple-Negative Breast Cancer Read Post »
Health TidingsAbivax Advances Obefazimod Toward FDA NDA for Ulcerative Colitis Abivax Advances Obefazimod Toward FDA NDA for Ulcerative Colitis Read Post »
Clinical TrialsFDA Advisory Panel Backs Replimune’s RP1 for Advanced Melanoma FDA Advisory Panel Backs Replimune’s RP1 for Advanced Melanoma Read Post »
Clinical TrialsKaryopharm Shifts Focus After Phase 3 Selinexor Trial Misses Primary Endpoi... Karyopharm Shifts Focus After Phase 3 Selinexor Trial Misses Primary Endpoi... Read Post »
Health Tidings Mergers & AcquisitionsAbCellera, Vertex Sign Deal to Develop Autoimmune T-Cell Engagers AbCellera, Vertex Sign Deal to Develop Autoimmune T-Cell Engagers Read Post »
New Drug ApprovalEU Approves Pfizer-BioNTech XFG COVID-19 Vaccine for 2026-2027 EU Approves Pfizer-BioNTech XFG COVID-19 Vaccine for 2026-2027 Read Post »
Health Tidings Mergers & AcquisitionsRelation, GSK Partner in $110M AI Drug Discovery Collaboration Relation, GSK Partner in $110M AI Drug Discovery Collaboration Read Post »
Health TidingsFDA Grants Priority Review to J&J’s Subcutaneous Amivantamab for ... FDA Grants Priority Review to J&J’s Subcutaneous Amivantamab for ... Read Post »
Health TidingsFDA Advisory Panel Recommends Against Deramiocel for DMD Cardiomyopathy FDA Advisory Panel Recommends Against Deramiocel for DMD Cardiomyopathy Read Post »
Health TidingsOmalizumab Outperformed Multiallergen Oral Immunotherapy in OUTMATCH Trial ... Omalizumab Outperformed Multiallergen Oral Immunotherapy in OUTMATCH Trial ... Read Post »
Clinical TrialsCTx-1301 Shows Significant ADHD Symptom Improvement in Phase 3 Trial CTx-1301 Shows Significant ADHD Symptom Improvement in Phase 3 Trial Read Post »
Clinical TrialsRalinepag Reduced Clinical Worsening Risk by 55% in Phase 3 PAH Trial Publi... Ralinepag Reduced Clinical Worsening Risk by 55% in Phase 3 PAH Trial Publi... Read Post »
Clinical TrialsPfizer’s LITFULO Meets Phase 3 Endpoints in Nonsegmental Vitiligo Pfizer’s LITFULO Meets Phase 3 Endpoints in Nonsegmental Vitiligo Read Post »
Health TidingsEyePoint Completes Enrollment in Phase 3 DURAVYU™ Trials for DME EyePoint Completes Enrollment in Phase 3 DURAVYU™ Trials for DME Read Post »
Mergers & AcquisitionsJohnson & Johnson Partners with Sail Biomedicines for In Vivo CAR-T The... Johnson & Johnson Partners with Sail Biomedicines for In Vivo CAR-T The... Read Post »
New Drug ApprovalTeleflex Receives FDA Approval for First Freeze-Dried Plasma Product in the... Teleflex Receives FDA Approval for First Freeze-Dried Plasma Product in the... Read Post »
Health TidingsMHRA and NICE Approve Aficamten for Obstructive Hypertrophic Cardiomyopathy MHRA and NICE Approve Aficamten for Obstructive Hypertrophic Cardiomyopathy Read Post »
Health TidingsFDA Grants Priority Review to PolyPid’s D-PLEX100 for Surgical Site I... FDA Grants Priority Review to PolyPid’s D-PLEX100 for Surgical Site I... Read Post »
Clinical TrialsNEJM Publishes Positive Phase 2b Results for Latigo’s LTG-001 in Post... NEJM Publishes Positive Phase 2b Results for Latigo’s LTG-001 in Post... Read Post »
Clinical TrialsDeramiocel Significantly Slows Upper Limb Function Decline in Advanced Duch... Deramiocel Significantly Slows Upper Limb Function Decline in Advanced Duch... Read Post »
Clinical TrialsViiV Healthcare Strengthens Evidence for Long-Acting HIV Therapies with Pos... ViiV Healthcare Strengthens Evidence for Long-Acting HIV Therapies with Pos... Read Post »
Health TidingsEuropean Commission Approves Opzelura for Adults with Moderate Atopic Derma... European Commission Approves Opzelura for Adults with Moderate Atopic Derma... Read Post »
Health TidingsFDA Grants Fast Track Designation to Insilico Medicine’s AI-Designed ... FDA Grants Fast Track Designation to Insilico Medicine’s AI-Designed ... Read Post »
Clinical TrialsCMG901 Improves Survival in Global Phase III Trial for CLDN18.2-Positive Ad... CMG901 Improves Survival in Global Phase III Trial for CLDN18.2-Positive Ad... Read Post »
Health TidingsOral Semaglutide Reduces Heavy Drinking in Phase 2 Trial, Supporting Furthe... Oral Semaglutide Reduces Heavy Drinking in Phase 2 Trial, Supporting Furthe... Read Post »
Health TidingsRepatha Wins CHMP Backing to Expand Cardiovascular Risk Reduction in High-R... Repatha Wins CHMP Backing to Expand Cardiovascular Risk Reduction in High-R... Read Post »
Health TidingsEuropean Commission Approves RINVOQ for Severe Alopecia Areata and Non-Segm... European Commission Approves RINVOQ for Severe Alopecia Areata and Non-Segm... Read Post »
Health TidingsFDA Raises Efficacy Concerns Over Replimune’s RP1 Before Advisory Com... FDA Raises Efficacy Concerns Over Replimune’s RP1 Before Advisory Com... Read Post »
