Ocugen announces FDA alignment for Phase 2/3 trial of gene therapy OCU410ST for Stargardt disease, showing promising initial results. Ocugen, Inc. announced it has received FDA approval to proceed ...
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Acurx signals progress in Phase 3 ibezapolstat program with $12M credit line following regulatory alignment
David Luci, President and CEO, highlighted several significant developments, including the closing of a $2.5 million registered direct offering and the receipt of positive regulatory guidance from the ...
Chemomab Therapeutics has announced that it has successfully completed its End-of-Phase 2 meeting with the FDA, aligning on the design of a single Phase 3 trial for its lead product candidate, ...
DUBLIN--(BUSINESS WIRE)-- ICON plc (ICLR), (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, has been rated as one of the top-performing contract research ...
"We are very pleased to have achieved alignment with the FDA on key aspects of our Phase 3 design for neflamapimod in DLB, including our selected endpoints and patient enrichment strategy," said Dr.
- Flexible Dosing and Extended Duration would be Important Differentiators from Existing Approved Therapies and Other Tyrosine Kinase Inhibitors in Development - ALPHARETTA, Ga., March 06, 2025 (GLOBE ...
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BioAtla outlines $800M peak sales target for Oz-V as FDA alignment paves way for phase III launch
Jay Short, Co-Founder, CEO & Chairman, emphasized that BioAtla is "currently in advanced stages to finalize a strategic transaction with a potential partner by year-end." He announced FDA alignment on ...
"We are very pleased to have achieved alignment with the FDA on key aspects of our Phase 3 design for neflamapimod in DLB, including our selected endpoints and patient enrichment strategy," said Dr.
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