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The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...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

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 ...
Nasdaq

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 ...
JD Supra

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
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Aardvark Therapeutics Expands Phase 3 HERO Trial Eligibility for ARD-101 in Prader-Willi Syndrome After FDA Protocol Alignment

Aardvark Therapeutics Inc. (NASDAQ:AARD) is one of the best young stocks with huge upside potential. On October 8, Aardvark Therapeutics announced that the company had reached alignment with the US ...
RAPS

FDA proposes uniform system for classifying protocol deviations

The US Food and Drug Administration (FDA) has issued draft guidance that proposes a uniform system for classifying protocol deviations in clinical studies to assist sponsors, clinical investigators, ...
The Globe and Mail

PDSB Q4 2025 Earnings Call Transcript

PDS Biotechnology Corporation (NASDAQ:PDSB) reported regulatory progress for its lead program by achieving FDA clearance of the VERSATILE-003 protocol amendment, which sets progression-free survival ...