Girl with Griscelli Syndrome Type II undergoes first haploidentical transplant at Miami hospital
Girl with Griscelli Syndrome Type II receives first haploidentical transplant at Miami hospital, offering new hope for ultra-rare genetic...
Elevar Presents Age-Stratified Camrelizumab-Rivoceranib Data After FDA Rejection
Elevar presents age-stratified camrelizumab-rivoceranib data from Phase 3 CARES-310 after two FDA rejections, signaling potential resubmission strategy.
PMV Pharma’s Rezatapopt Achieves 44% Response Rate in TP53 Y220C Ovarian Cancer
PMV Pharma's rezatapopt achieves 44% response rate in TP53 Y220C ovarian cancer patients, positioning the drug for potential FDA...
SRD-002 Gene Therapy Shows Sustained HFpEF Improvement at 12 Months
SRD-002 gene therapy shows sustained HFpEF improvement at 12 months with 80% PCWP normalization from a single intracoronary dose.
Astellas donates tacrolimus to U.S. API reserve, strikes pricing deal
Astellas donates tacrolimus active pharmaceutical ingredient to U.S. Strategic API Reserve and strikes voluntary Medicaid pricing agreement with government.
Canada’s Drug Agency Issues Positive Reimbursement Recommendation for Lecanemab
Canada's drug agency issues positive reimbursement recommendation for lecanemab after reversing its February rejection, opening access for patients with...
Ascletis Doses First Patient in ASC30 Phase III Obesity Trial
Ascletis doses first patient in ASC30 Phase III obesity trial, advancing oral GLP-1 agonist against established semaglutide competition through...
enVast Mechanical Thrombectomy Meets Primary Endpoint in Large-Thrombus STEMI Trial
Mechanical thrombectomy for STEMI with large thrombus burden reduced infarct size by 26% in the NATURE trial, meeting its...
Cumberland Seeks FDA Action on Ifetroban DMD Data Before Extension Study Complete
Cumberland Pharmaceuticals seeks FDA action on ifetroban DMD data from an ongoing extension study, positioning the drug for cardiomyopathy...
Akeso’s ivonescimab meets OS endpoint in EGFR-TKI-resistant NSCLC Phase III
Akeso's ivonescimab met overall survival endpoint in Phase III trial for EGFR-TKI-resistant NSCLC, with consistent results across Western and...