FDA raises no concerns over Auxora safety data, CalciMedica advances trial

CalciMedica Inc. CALC said on Wednesday the U.S. Food and Drug Administration (FDA) raised no objections to amendments made ...

CalciMedica Announces Clinical Development of Auxora May Proceed Following FDA Review of KOURAGE Trial Interim Safety Data

CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for ...
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Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome

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 ...
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FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment

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 ...
Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...

CalciMedica, Inc.: CalciMedica Announces Clinical Development of Auxora May Proceed Following FDA Review of KOURAGE Trial Interim Safety Data

FDA reviewed a protocol amendment and interim safety data from the KOURAGE trial evaluating Auxora in AKI patients No comments or questions were received Confirms CalciMedica's ...