PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint

PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101 PRINCETON, N.J., Jan. 09, 2026 (GLOBE ...
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 ...
Investing.com India

PDS Biotech stock soars after FDA meeting provides accelerated approval path

The submission follows a Type C meeting with the FDA in December 2025 to discuss the proposed accelerated approval pathway. The amendment is supported by positive final results from the company’s ...
Seeking Alpha

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. (AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate ...
Seeking Alpha

CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM

HOUSTON, June 23, 2022 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and ...
Nasdaq

BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment

MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based ...
Targeted Oncology

FDA Type B Meeting Offers Direction for Rhenium Re 186 Obisbemeda in LM

A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...
Business Wire

Ankyra Therapeutics Announces Trial in Progress Poster Presentation at 2024 ASCO Meeting and Approval of ANK-101 Phase 1 Protocol Amendment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage oncology company developing anchored immunotherapies to improve the therapeutic window for immuno-oncology drugs, announced ...

PDS Biotechnology Corporation: PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint

PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101 PRINCETON, N.J., Jan. 09, 2026 (GLOBE NEW ...