Clearside Biomedical announces successful End-of-Phase 2 meeting for CLS-AX
Clearside Biomedical (CLSD) announced the receipt of the formal meeting minutes from its recent End-of-Phase 2 meeting with the U.S. Food and ...
Axsome Therapeutics expects to submit sNDA for AXS-05 in Q3
Axsome Therapeutics (AXSM) has received formal pre-New Drug Application meeting minutes from the U.S. Food and Drug Administration supporting a ...
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Clearside Biomedical Details Phase 3 Program for CLS-AX in Wet AMD Following Positive FDA Meeting
Receipt of formal meeting minutes from the FDA confirming key elements for two proposed Phase 3 pivotal trials indicates regulatory progress and alignment with the FDA. Positive outcome of the End ...
Clearside Biomedical Announces Successful End-of-Phase 2 Meeting with the FDA and Alignment on Phase 3 Plans for Suprachoroidal CLS-AX in Wet AMD
CLS-AX Phase 3 Program Designed to Maximize Commercial Potential in Wet AMD - - Flexible Dosing and Extended Duration would be Important Differentiators from Existing Approved Therapies and Other ...