Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

Press Release Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470U.S. NDA submission on track for summer 2026Nicox ...
Business Insider

Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)

LOS ALTOS, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for ...
Seeking Alpha

Glaukos Announces US FDA Approval of NDA Supplement Allowing for Re-Administration of iDose® TR

ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (GKOS), an ophthalmic pharmaceutical and medical technology focused on novel therapies for the treatment of glaucoma, corneal disorders, and ...
Morningstar

VivaVision Biotech Receives Positive Written Feedback from FDA - VVN461HD New Drug Application (NDA) Requires Only a "Single Phase III" Pivotal Clinical Study in the U.S. for ...

WENZHOU, China, Jan. 6, 2026 /PRNewswire/ -- Recently, VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs, ...