Health TidingsArialys Therapeutics Receives FDA Fast Track Designation for ART5803 in Ant... Arialys Therapeutics Receives FDA Fast Track Designation for ART5803 in Ant... Read Post »
Drugs Safety AlertEMA PRAC Adds Meningioma Warning for Desogestrel Contraceptives EMA PRAC Adds Meningioma Warning for Desogestrel Contraceptives Read Post »
Health TidingsOrelabrutinib Becomes First BTK Inhibitor to Show Clinical Efficacy in Lupu... Orelabrutinib Becomes First BTK Inhibitor to Show Clinical Efficacy in Lupu... Read Post »
Clinical TrialsRisvutatug Rezetecan Improves Survival in Phase III ARTEMIS-008 Trial, Mark... Risvutatug Rezetecan Improves Survival in Phase III ARTEMIS-008 Trial, Mark... Read Post »
New Drug ApprovalSanofi Wins US FDA Approval for Subcutaneous Sarclisa Escena, First Cancer ... Sanofi Wins US FDA Approval for Subcutaneous Sarclisa Escena, First Cancer ... Read Post »
Clinical TrialsRoche Discontinues Tominersen and RG6496 Development for Huntington’s... Roche Discontinues Tominersen and RG6496 Development for Huntington’s... Read Post »
Health Tidings Mergers & AcquisitionsSerum Institute, DNDi Advance VIS513 Into Global Phase III Dengue Trial Serum Institute, DNDi Advance VIS513 Into Global Phase III Dengue Trial Read Post »
Clinical TrialsForte Reports Positive Phase 1b Results for FB102 in Vitiligo Forte Reports Positive Phase 1b Results for FB102 in Vitiligo Read Post »
ResearchISSCR Reports 12-Month STEM-PD Trial Findings in Parkinson’s Disease ISSCR Reports 12-Month STEM-PD Trial Findings in Parkinson’s Disease Read Post »
Health TidingsSaol Resubmits FDA Application for SL1009 in Rare Pediatric Mitochondrial D... Saol Resubmits FDA Application for SL1009 in Rare Pediatric Mitochondrial D... Read Post »
Clinical TrialsLEO Pharma Reports Positive Phase II TRAPEDS-1 Data Supporting Long-Term Sa... LEO Pharma Reports Positive Phase II TRAPEDS-1 Data Supporting Long-Term Sa... Read Post »
Clinical TrialsFate Therapeutics Wins FDA IND Clearance for FT839 Dual-CAR T-Cell Therapy ... Fate Therapeutics Wins FDA IND Clearance for FT839 Dual-CAR T-Cell Therapy ... Read Post »
GenericsFDA Accepts Amneal and Adalvo ANDAs for Generic Tirzepatide Autoinjectors FDA Accepts Amneal and Adalvo ANDAs for Generic Tirzepatide Autoinjectors Read Post »
Clinical TrialsIpsen Reports Positive Phase III BEOND Results for Dysport in Episodic and ... Ipsen Reports Positive Phase III BEOND Results for Dysport in Episodic and ... Read Post »
Clinical TrialsINmune Bio Reports Early MRI Evidence of XPro Activity in Phase 2 Alzheimer... INmune Bio Reports Early MRI Evidence of XPro Activity in Phase 2 Alzheimer... Read Post »
Clinical TrialsBiocytogen, Whitehawk Partner to Develop Bispecific Antibody-Drug Conjugate... Biocytogen, Whitehawk Partner to Develop Bispecific Antibody-Drug Conjugate... Read Post »
Health Tidings Mergers & AcquisitionsTeva Secures Global Rights to Polpharma Biologics’ Proposed Biosimilar to... Teva Secures Global Rights to Polpharma Biologics’ Proposed Biosimilar to... Read Post »
Health Tidings Mergers & AcquisitionsBayer Launches Clinical Trials Alliance With CU Anschutz Bayer Launches Clinical Trials Alliance With CU Anschutz Read Post »
GenericsTeva, Samsung Bioepis Partner to Commercialize OPUVIZ Aflibercept Biosimila... Teva, Samsung Bioepis Partner to Commercialize OPUVIZ Aflibercept Biosimila... Read Post »
Health TidingsAllotera Secures $35M to Advance Pivotal Allogeneic CAR‑T Sofi‑cel in T... Allotera Secures $35M to Advance Pivotal Allogeneic CAR‑T Sofi‑cel in T... Read Post »
Clinical TrialsBiocon Reports New Phase III Evidence for Yesafili Biosimilar Biocon Reports New Phase III Evidence for Yesafili Biosimilar Read Post »
Clinical TrialsAstraZeneca, Ionis’ Wainua Misses Phase III Endpoint in ATTR-CM Trial AstraZeneca, Ionis’ Wainua Misses Phase III Endpoint in ATTR-CM Trial Read Post »
Clinical TrialsSatellos Reports Interim Phase 2 TRAILHEAD Data: SAT‑3247 Shows Muscle Co... Satellos Reports Interim Phase 2 TRAILHEAD Data: SAT‑3247 Shows Muscle Co... Read Post »
Clinical TrialsRhythm Reports NEJM Publication of IMCIVREE Trial in Hypothalamic Obesity Rhythm Reports NEJM Publication of IMCIVREE Trial in Hypothalamic Obesity Read Post »
Health TidingsMerck Secures FDA Breakthrough Therapy Designation for Enpatoran in Lupus P... Merck Secures FDA Breakthrough Therapy Designation for Enpatoran in Lupus P... Read Post »
Clinical TrialsPrilenia Launches Global Phase 3 PRECISE-HD Trial of Pridopidine for Huntin... Prilenia Launches Global Phase 3 PRECISE-HD Trial of Pridopidine for Huntin... Read Post »
Clinical TrialsUCB Reports Sustained Long‑Term Efficacy of Rozanolixizumab and Zilucopla... UCB Reports Sustained Long‑Term Efficacy of Rozanolixizumab and Zilucopla... Read Post »
Health TidingsGrünenthal Receives FDA Orphan Drug and Rare Pediatric Disease Designation... Grünenthal Receives FDA Orphan Drug and Rare Pediatric Disease Designation... Read Post »
Health TidingsArcutis’ ZORYVE Cream sNDA Accepted by FDA for Infants with Atopic Dermat... Arcutis’ ZORYVE Cream sNDA Accepted by FDA for Infants with Atopic Dermat... Read Post »
Clinical TrialsMAIA Reports 90.5% Disease Control Rate with Ateganosine Plus Cemiplimab in... MAIA Reports 90.5% Disease Control Rate with Ateganosine Plus Cemiplimab in... Read Post »
Health Tidings Mergers & AcquisitionsSino Biopharmaceutical Licenses COPD Candidate TQC3721 to AstraZeneca in Up... Sino Biopharmaceutical Licenses COPD Candidate TQC3721 to AstraZeneca in Up... Read Post »
Health TidingsImmunome’s Varegacestat NDA Accepted by FDA for Desmoid Tumors Immunome’s Varegacestat NDA Accepted by FDA for Desmoid Tumors Read Post »
Health Tidings Mergers & AcquisitionsChemomab, Scipher Merge to Advance Nebokitug in Rheumatoid Arthritis Chemomab, Scipher Merge to Advance Nebokitug in Rheumatoid Arthritis Read Post »
Clinical TrialsKeenova’s XIAFLEX Delivers Positive Phase 3 Results in Plantar Fibrom... Keenova’s XIAFLEX Delivers Positive Phase 3 Results in Plantar Fibrom... Read Post »
Clinical TrialsSeres Reports Positive SER-155 Results in Immune Checkpoint Enterocolitis Seres Reports Positive SER-155 Results in Immune Checkpoint Enterocolitis Read Post »
New Drug ApprovalMHRA Approves Nerandomilast for Idiopathic Pulmonary Fibrosis and Progressi... MHRA Approves Nerandomilast for Idiopathic Pulmonary Fibrosis and Progressi... Read Post »
Health TidingsFDA Aligns With OKYO’s NEPTUNE Phase 3 Trial of Urcosimod in Neuropathic ... FDA Aligns With OKYO’s NEPTUNE Phase 3 Trial of Urcosimod in Neuropathic ... Read Post »
Health TidingsVanda’s VCA-894A Receives FDA Rare Pediatric Disease Designation for Ultr... Vanda’s VCA-894A Receives FDA Rare Pediatric Disease Designation for Ultr... Read Post »
ResearchGalderma Global Survey Reveals Skin Quality Concerns Affect 90% of People, ... Galderma Global Survey Reveals Skin Quality Concerns Affect 90% of People, ... Read Post »
Health TidingsAgios’ Mitapivat Gains FDA Priority Review for Sickle Cell Disease Agios’ Mitapivat Gains FDA Priority Review for Sickle Cell Disease Read Post »
Clinical TrialsTurn Therapeutics Reports Interim Phase 2 Results, Finalizes Stage 2 Trial ... Turn Therapeutics Reports Interim Phase 2 Results, Finalizes Stage 2 Trial ... Read Post »
New Drug ApprovalFDA Grants Accelerated Approval to TRUTAKNA for IgA Nephropathy FDA Grants Accelerated Approval to TRUTAKNA for IgA Nephropathy Read Post »
Health TidingsAxsome Moves Solriamfetol into Late-Stage Trial for Children with ADHD Axsome Moves Solriamfetol into Late-Stage Trial for Children with ADHD Read Post »
Health Tidings Mergers & AcquisitionsPraxis Partners with Remagine Labs to Develop Transdermal Patch for Ulixaca... Praxis Partners with Remagine Labs to Develop Transdermal Patch for Ulixaca... Read Post »
Health TidingsFDA Confirms Phase 3 Path for Alterity’s ATH434 in Multiple System Atroph... FDA Confirms Phase 3 Path for Alterity’s ATH434 in Multiple System Atroph... Read Post »
New Drug ApprovalFDA Expands WILATE Prophylaxis Approval to Children Under 6 With von Willeb... FDA Expands WILATE Prophylaxis Approval to Children Under 6 With von Willeb... Read Post »
Health TidingsMeiraGTx Wins Up to $400 Million Funding for Gene Therapy Pipeline MeiraGTx Wins Up to $400 Million Funding for Gene Therapy Pipeline Read Post »
Health TidingsRevolution Medicines Advances Daraxonrasib Toward Europe After EMA Starts P... Revolution Medicines Advances Daraxonrasib Toward Europe After EMA Starts P... Read Post »
Health TidingsInsilico Medicine Advances AI-Discovered Rentosertib into Phase III Trial f... Insilico Medicine Advances AI-Discovered Rentosertib into Phase III Trial f... Read Post »
Clinical TrialsCompass Pathways Reports 6-Month Phase 3 Data Showing Durable COMP360 Benef... Compass Pathways Reports 6-Month Phase 3 Data Showing Durable COMP360 Benef... Read Post »
