Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label 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 »
Clinical TrialsMannKind Advances Inhaled Nintedanib with Positive Phase 1b IPF Data MannKind Advances Inhaled Nintedanib with Positive Phase 1b IPF Data Read Post »
New Drug ApprovalFDA Approves Viatris’ Gwyn Lo Contraceptive Patch for Pregnancy Preve... FDA Approves Viatris’ Gwyn Lo Contraceptive Patch for Pregnancy Preve... Read Post »
Clinical TrialsAtea Reports Positive Phase 3 Results for BEM/RZR in Hepatitis C Atea Reports Positive Phase 3 Results for BEM/RZR in Hepatitis C Read Post »
Health TidingsLUCERNA Trial Evaluates New First-Line Combination for CLDN18.2-Positive Ga... LUCERNA Trial Evaluates New First-Line Combination for CLDN18.2-Positive Ga... Read Post »
Clinical TrialsSeaweed-Derived Fucoidan Improves BPH Symptoms in Randomized Clinical Trial Seaweed-Derived Fucoidan Improves BPH Symptoms in Randomized Clinical Trial Read Post »
Clinical TrialsCaliway Submits FDA IND for Phase 2 Trial of CBL-514 Plus Tirzepatide to Re... Caliway Submits FDA IND for Phase 2 Trial of CBL-514 Plus Tirzepatide to Re... Read Post »
Clinical TrialsEMA Clears Investigator-Initiated Phase 1b/2 Trial of LP-184 in Biomarker-S... EMA Clears Investigator-Initiated Phase 1b/2 Trial of LP-184 in Biomarker-S... Read Post »
Health TidingsFDA Grants Fast Track Designation to HAYA’s HTX-001 for nHCM FDA Grants Fast Track Designation to HAYA’s HTX-001 for nHCM Read Post »
Mergers & AcquisitionsCSL Reports Positive Phase 3b Results for ANDEMBRY in Children With HAE CSL Reports Positive Phase 3b Results for ANDEMBRY in Children With HAE Read Post »
Health TidingsREGENERA Shows Durable Benefits One Year After Lumpectomy REGENERA Shows Durable Benefits One Year After Lumpectomy Read Post »
Health TidingsOrganogenesis Publishes Positive Affinity Trial Results for Venous Leg Ulce... Organogenesis Publishes Positive Affinity Trial Results for Venous Leg Ulce... Read Post »
Health TidingsGSK’s Risvutatug Rezetecan Extends Progression-Free Survival in Phase III... GSK’s Risvutatug Rezetecan Extends Progression-Free Survival in Phase III... Read Post »
Clinical TrialsProMIS Reports Positive Phase 1b PMN310 Interim Results in Alzheimer’... ProMIS Reports Positive Phase 1b PMN310 Interim Results in Alzheimer’... Read Post »
Clinical TrialsAltimmune Reports Positive Phase 2 Results for Pemvidutide in Alcohol Use D... Altimmune Reports Positive Phase 2 Results for Pemvidutide in Alcohol Use D... Read Post »
Mergers & AcquisitionsEntera Bio Positions EB613 for Phase 3 Osteoporosis Studies Entera Bio Positions EB613 for Phase 3 Osteoporosis Studies Read Post »
Clinical TrialsOryzon Reports Positive Iadademstat Data in First-Line AML Oryzon Reports Positive Iadademstat Data in First-Line AML Read Post »
Health Tidings Mergers & AcquisitionsBioMarin, n-Lorem Advance First Mutation-Targeted Therapy for Newly Discove... BioMarin, n-Lorem Advance First Mutation-Targeted Therapy for Newly Discove... Read Post »
Health TidingsIDEAYA Starts IDE892 Phase 1/2 Expansion in MTAP-Deleted PDAC and NSCLC IDEAYA Starts IDE892 Phase 1/2 Expansion in MTAP-Deleted PDAC and NSCLC Read Post »
Clinical TrialsNeuroScientific Advances StemSmart into Phase 2 After 80% Clinical Response... NeuroScientific Advances StemSmart into Phase 2 After 80% Clinical Response... Read Post »
Health TidingsTwo-Drug Dovato Matches Three-Drug Biktarvy in Viral Suppression Trial Two-Drug Dovato Matches Three-Drug Biktarvy in Viral Suppression Trial Read Post »
Clinical TrialsBambusa’s BBT001 Shows Rapid Eczema and Itch Relief in Phase 1 Trial, Sup... Bambusa’s BBT001 Shows Rapid Eczema and Itch Relief in Phase 1 Trial, Sup... Read Post »
Clinical TrialsPhase 2b Trial Fully Enrolled as Veru Tests Enobosarm to Preserve Muscle Du... Phase 2b Trial Fully Enrolled as Veru Tests Enobosarm to Preserve Muscle Du... Read Post »
Health TidingsFDA Clears Path for Gossamer’s Seralutinib NDA Submission in PAH FDA Clears Path for Gossamer’s Seralutinib NDA Submission in PAH Read Post »
Health Tidings Mergers & Acquisitionsargenx Adds First-in-Class FB102 Through $2.2B Forte Biosciences Acquisitio... argenx Adds First-in-Class FB102 Through $2.2B Forte Biosciences Acquisitio... Read Post »
Health TidingsMapLight Reports Positive Phase 2 Results for ML-007C-MA in Schizophrenia MapLight Reports Positive Phase 2 Results for ML-007C-MA in Schizophrenia Read Post »
Health TidingsInnoCare’s Fadeucravacitinib Meets Phase III Endpoint in Plaque Psori... InnoCare’s Fadeucravacitinib Meets Phase III Endpoint in Plaque Psori... Read Post »
Clinical TrialsSonesitatug Vedotin Improves Survival in Phase III Gastric Cancer Trial Sonesitatug Vedotin Improves Survival in Phase III Gastric Cancer Trial Read Post »
Clinical TrialsKura Reports Positive Phase 1a Data for Darlifarnib Plus Cabozantinib in Ad... Kura Reports Positive Phase 1a Data for Darlifarnib Plus Cabozantinib in Ad... Read Post »
Clinical TrialsUltomiris Misses Phase III HSCT-TMA Endpoint in Adults Ultomiris Misses Phase III HSCT-TMA Endpoint in Adults Read Post »
Clinical TrialsOrganon Reports Positive Phase 3 VTAMA Data in Atopic Dermatitis Organon Reports Positive Phase 3 VTAMA Data in Atopic Dermatitis Read Post »
