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 »
Health Tidings Mergers & AcquisitionsYarrow Bioscience Initiates Phase 2 Trial of Anti-TSHR Antibody YB-101 for ... Yarrow Bioscience Initiates Phase 2 Trial of Anti-TSHR Antibody YB-101 for ... Read Post »
Clinical TrialsArgenica Reports Positive Phase 2 Data for Xaranetide, Prepares FDA Clinica... Argenica Reports Positive Phase 2 Data for Xaranetide, Prepares FDA Clinica... Read Post »
New Drug ApprovalFDA Approves Otsuka’s SIMTRIYO as First Triple Reuptake Inhibitor for... FDA Approves Otsuka’s SIMTRIYO as First Triple Reuptake Inhibitor for... Read Post »
Health TidingsAmgen Defends TAVNEOS With New FDA Submission to Prevent Proposed U.S. Mark... Amgen Defends TAVNEOS With New FDA Submission to Prevent Proposed U.S. Mark... Read Post »
Regulatory & Health PolicyFDA, CDC, and USDA Unveil New Antimicrobial Resistance Roadmap FDA, CDC, and USDA Unveil New Antimicrobial Resistance Roadmap Read Post »
GenericsFDA Approves First OTC Tylenol with Naproxen for 12-Hour Pain Relief FDA Approves First OTC Tylenol with Naproxen for 12-Hour Pain Relief Read Post »
Health TidingsHEMGENIX Achieves 100 Commercial Treatments for Adults with Hemophilia B HEMGENIX Achieves 100 Commercial Treatments for Adults with Hemophilia B Read Post »
Clinical TrialsSanofi Will Not Seek Approval for Amlitelimab in Atopic Dermatitis Sanofi Will Not Seek Approval for Amlitelimab in Atopic Dermatitis Read Post »
New Drug ApprovalFDA Approves LYTENAVA as First Ophthalmic Bevacizumab for Wet AMD FDA Approves LYTENAVA as First Ophthalmic Bevacizumab for Wet AMD Read Post »
New Drug ApprovalFour CHMP Recommendations Could Reshape Care in Psoriasis, AMD, Asthma, and... Four CHMP Recommendations Could Reshape Care in Psoriasis, AMD, Asthma, and... Read Post »
Health TidingsFDA Advisory Committee Recommends Four Peptides for 503A Compounding List D... FDA Advisory Committee Recommends Four Peptides for 503A Compounding List D... Read Post »
Health TidingsMerck Launches Global Access Plan for Once-Monthly HIV Prevention Pill Alim... Merck Launches Global Access Plan for Once-Monthly HIV Prevention Pill Alim... Read Post »
Clinical TrialsIpsen’s Phase 3 BOLD Trial of Bylvay Fails to Improve Native Liver Surviv... Ipsen’s Phase 3 BOLD Trial of Bylvay Fails to Improve Native Liver Surviv... Read Post »
New Drug ApprovalFDA Approves First Subcutaneous Furosemide Autoinjector for HF and CKD FDA Approves First Subcutaneous Furosemide Autoinjector for HF and CKD Read Post »
Health TidingsNanvuranlat Enters First-Line BTC Trial With New 46-Hour Infusion Strategy Nanvuranlat Enters First-Line BTC Trial With New 46-Hour Infusion Strategy Read Post »
Clinical TrialsTLX400-Tx Achieves 80% Disease Control in Advanced Medullary Thyroid Cancer TLX400-Tx Achieves 80% Disease Control in Advanced Medullary Thyroid Cancer Read Post »
Clinical TrialsGenmab and AbbVie Clarify EPCORE DLBCL-1 Missed U.S. Primary Endpoint After... Genmab and AbbVie Clarify EPCORE DLBCL-1 Missed U.S. Primary Endpoint After... Read Post »
Health TidingsFDA Grants Fast Track Status to Oral Orexin 2 Agonist Lu AH69593 for Narcol... FDA Grants Fast Track Status to Oral Orexin 2 Agonist Lu AH69593 for Narcol... Read Post »
Health TidingsInsilico Advances AI-Discovered Non-Opioid Pain Candidate ISM9528 Toward Cl... Insilico Advances AI-Discovered Non-Opioid Pain Candidate ISM9528 Toward Cl... Read Post »
Health TidingsTecvayli Plus Talvey Significantly Improves Survival in Phase 3 Multiple My... Tecvayli Plus Talvey Significantly Improves Survival in Phase 3 Multiple My... Read Post »
