Submission
GSK, Spero Report Major Phase 3 Win for UTI Antibiotic; Spero’s Stock Surges
GSK; Spero Therapeutics; tebipenem HBr; Phase 3 trial; UTI antibiotic; complicated urinary tract infection; PIVOT-PO trial; stock surge; clinical trial results; FDA submission
Merck’s HIV Combo Treatment Advances Towards FDA Filing
Doravirine/islatravir (DOR/ISL) combination, Phase 3 trials, Viral suppression, Once-daily oral regimen, FDA submission
Kura Oncology and Kyowa Kirin Report Positive Phase 2 Results for Ziftomenib in AML, Prepare for FDA Submission
Ziftomenib, AML, NPM1-mutant, Phase 2 trial, KOMET-001, FDA submission, Kura Oncology, Kyowa Kirin
Regeneron’s EYLEA HD Succeeds in Phase 3 Trial for Retinal Vein Occlusion, Paving Way for 2025 FDA Submission
EYLEA HD, Aflibercept, Retinal Vein Occlusion (RVO), Phase 3 QUASAR Trial, Extended Dosing Intervals, FDA Submission 2025, Regeneron Pharmaceuticals
Kyowa Kirin Invests $330M in Kura’s Leukemia Drug, Gaining Shared Rights Ahead of FDA Submission
Kyowa Kirin, Kura, leukemia drug, FDA submission, pharmaceutical investment
Adaptimmune Prepares for Next FDA Submission Following Success in Pivotal Sarcoma Study
Adaptimmune, FDA submission, sarcoma study, afami-cel, lete-cel, cell therapy, synovial sarcoma, cancer treatment
Sangamo Therapeutics Aligns with FDA on Accelerated Approval Pathway for ST-920 Gene Therapy in Fabry Disease
Sangamo Therapeutics, FDA, Accelerated Approval Pathway, ST-920, Fabry Disease, Gene Therapy, BLA Submission
Biohaven Achieves Breakthrough in Spinocerebellar Ataxia Treatment with Positive Pivotal Study Results for Troriluzole
Biohaven, Troriluzole, Spinocerebellar Ataxia (SCA), Pivotal Study Results, Neurodegenerative Disease, FDA Submission, New Drug Application (NDA)
Exact Sciences Advances Toward FDA Submission with Promising Blood-Based Colorectal Cancer Screening Test
Exact Sciences, Blood-Based Colorectal Cancer Screening, ESMO 2024, FDA Submission, Colorectal Cancer Detection, Advanced Precancerous Lesions
Nuvation Bio Advances with Pooled Data for ROS1-positive Lung Cancer Treatment, Eyes FDA Submission
Nuvation Bio, ROS1-positive NSCLC, taletrectinib, TRUST-I, TRUST-II, FDA submission, lung cancer treatment