PDS Biotech Amends Phase 3 Trial for Accelerated Approval
PDS Biotechnology has amended its Phase 3 VERSATILE-003 trial to add progression-free survival as an interim primary endpoint to...
FDA Approves Phase 2 Trial for Daré’s Promising HPV Drug
FDA has cleared Daré Bioscience’s IND for DARE-HPV, a fixed-dose lopinavir/ritonavir vaginal insert, enabling a Phase 2 study in...
Cyclerion Advances CYC-126 Phase 2 Study With FDA Feedback
Cyclerion received positive written FDA feedback on its planned Phase 2 proof‑of‑concept study of CYC‑126 in treatment‑resistant depression, with...
Ocular Therapeutix to Announce SOL-1 Wet AMD Trial Data
Ocular Therapeutix will disclose topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI (OTX-TKI) in wet age-related...
InnoCare Doses First Patient in Urticaria Trial in China
InnoCare Pharma has dosed the first patient in a seamless Phase II/III trial of its oral TYK2 inhibitor soficitinib...
Lyell Launches First Head-to-Head CAR T-Cell Lymphoma Trial
Updated data presented at ASH 2025 set the clinical bar Lyell now intends to clear in registration: in third-line-plus...
InnoCare Doses First Patient in Soficitinib Urticaria Trial
InnoCare has dosed the first patient in a Phase II/III trial of its oral TYK2 inhibitor soficitinib (ICP-332) for...
Annovis Alzheimer’s Drug Advances to Pivotal Phase 3 Trial
An independent DSMB found no safety concerns at six months in Annovis Bio’s pivotal Phase 3 Alzheimer’s trial of...
ImmunoSensor Doses First AGS Patient in New Phase 1b Study
Phase 1a data in healthy volunteers showed IMSB301 was well tolerated across a broad dose range, produced dose-dependent and...
Vaxcyte Doses First Adults in VAX-31 Phase 3 Vaccine Trial
In prior adult Phase 1/2 data, VAX-31 produced robust opsonophagocytic activity across all 31 serotypes, met superiority criteria on...