Aquestive Resubmits Anaphylm NDA to FDA
WARREN, N.J. — September 17, 2026 Aquestive Therapeutics announced the resubmission of its New Drug Application (NDA) to the...
NDA resubmission
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AGC Biologics Strengthens Global CDMO Leadership
YOKOHAMA, Japan, July 28, 2026 AGC Biologics has signed a long-term commercial manufacturing agreement valued at hundreds of millions...
Saol Therapeutics Advances SL1009 in FDA Review
ROSWELL, Ga., DUBLIN, Ireland, and HAMILTON, Bermuda, July 28, 2026 Saol Therapeutics has announced that the U.S. Food and...
Camurus NDA Resubmission for CAM2029 Accepted by FDA
LUND, Sweden, July 17, 2026 Camurus announced that the U.S. Food and Drug Administration (FDA) has accepted for review...
FDA Issues CRL for Anaphylm, Citing Human Factors Gaps
WARREN, N.J., Feb. 2, 2026 — Aquestive Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued...
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Unicycive Therapeutics to Resubmit OLC NDA After FDA Type A Meeting
Los Altos, California, October 28, 2025 — Unicycive Therapeutics, Inc., a clinical-stage biopharmaceutical company developing treatments for kidney disease,...
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