NDA Acceptance

PALO ALTO, Calif., July 22, 2026 BridgeBio has reached a significant regulatory milestone after the U.S. Food and Drug...

ZUG, Switzerland, July 6, 2026 Pharvaris announced that the U.S. Food and Drug Administration (FDA) has accepted the New...

PARAMUS, N.J., June 15, 2026 SK Life Science, Inc. has announced that the U.S. Food and Drug Administration (FDA)...

BASEL, Switzerland, June 2, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the New...

SOUTH SAN FRANCISCO, Calif., June 1, 2026 Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted...

WALTHAM, Mass. and BOULDER, Colo., May 28, 2026 Cogent Biosciences has announced a major regulatory milestone with the U.S....

Melbourne, Australia & Indianapolis, USA | April 10, 2026 Telix Pharmaceuticals has announced that the U.S. Food and Drug...

Hong Kong / Shanghai | December 30, 2025 — HUTCHMED announced that China’s drug regulator has accepted the New...