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 »
New Drug ApprovalAstraZeneca’s Etcamah Wins EU Approval for ESR1-Mutated HR-Positive Advan... AstraZeneca’s Etcamah Wins EU Approval for ESR1-Mutated HR-Positive Advan... Read Post »
New Drug ApprovalChina Approves Takeda’s ORZEYFUL for Narcolepsy Type 1 China Approves Takeda’s ORZEYFUL for Narcolepsy Type 1 Read Post »
Health TidingsCrystalys Therapeutics Raises $130 Million to Advance Phase 3 Development o... Crystalys Therapeutics Raises $130 Million to Advance Phase 3 Development o... Read Post »
Clinical TrialsZydus Advances Desidustat into Phase 3 Trial for Sickle Cell Disease Anemia... Zydus Advances Desidustat into Phase 3 Trial for Sickle Cell Disease Anemia... Read Post »
Clinical TrialsRetatrutide Shows Strong Weight Loss in Adults With Obesity and Type 2 Diab... Retatrutide Shows Strong Weight Loss in Adults With Obesity and Type 2 Diab... Read Post »
Health TidingsNHS England Introduces Fampridine for Walking Difficulties in Multiple Scle... NHS England Introduces Fampridine for Walking Difficulties in Multiple Scle... Read Post »
Mergers & AcquisitionsArcus and Summit Launch Casdatifan–Ivonescimab Trial in Metastatic Kidney... Arcus and Summit Launch Casdatifan–Ivonescimab Trial in Metastatic Kidney... Read Post »
ResearchReview Supports Bradykinin B2 Receptor as a Validated Target in Bradykinin-... Review Supports Bradykinin B2 Receptor as a Validated Target in Bradykinin-... Read Post »
Clinical TrialsFDA Accepts Daraxonrasib NDA for Previously Treated Metastatic Pancreatic C... FDA Accepts Daraxonrasib NDA for Previously Treated Metastatic Pancreatic C... Read Post »
Health TidingsPositive TALAPRO-3 Data Earn FDA Priority Review for TALZENNA Plus XTANDI Positive TALAPRO-3 Data Earn FDA Priority Review for TALZENNA Plus XTANDI Read Post »
New Drug ApprovalFDA Approves GSK’s Jideytro for Previously Treated ROS1-Positive Adva... FDA Approves GSK’s Jideytro for Previously Treated ROS1-Positive Adva... Read Post »
Health TidingsBridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1 BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1 Read Post »
Health TidingsFDA Grants Orphan Drug Status to Affinia’s AFTX-201 for BAG3-Associat... FDA Grants Orphan Drug Status to Affinia’s AFTX-201 for BAG3-Associat... Read Post »
Health TidingsRadiopharm’s RAD101 PET Imaging Meets Phase 2b Primary Endpoint in Re... Radiopharm’s RAD101 PET Imaging Meets Phase 2b Primary Endpoint in Re... Read Post »
Health TidingsPeer-Reviewed Phase 1 Data Support TLX591-Tx as a Differentiated PSMA-Targe... Peer-Reviewed Phase 1 Data Support TLX591-Tx as a Differentiated PSMA-Targe... Read Post »
Health TidingsRibo’s Vortosiran Cuts Factor XI Activity by 92% in Phase 2a Coronary... Ribo’s Vortosiran Cuts Factor XI Activity by 92% in Phase 2a Coronary... Read Post »
Clinical TrialsArrowhead’s Phase 3 SHASTA Trials Show Plozasiran Cuts Triglycerides ... Arrowhead’s Phase 3 SHASTA Trials Show Plozasiran Cuts Triglycerides ... Read Post »
