SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics ...
Protocol teams can invest months in expert review and still face costly amendments, frozen enrollment and delayed Phase III ...
SUNNYVALE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary ...
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics ...
Management described seeking an amendment to the VERSATILE-003 protocol to elevate progression-free survival (PFS) as a surrogate primary endpoint, in addition to maintaining median overall survival ...
Regulatory alignment from the FDA and MD Anderson IRB supports resumption of enrollment in a U.S./European proof-of-concept tasquinimod study for myelofibrosis. Protocol changes introduce a more ...
Expanded treatment in community settings will reduce patient burden Option to redose patients granted in both Ntrust-1 and Ntrust-2 studies Rheumatoid arthritis cohort to be added to Ntrust-2 Dosing ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...