Roche Secures FDA sBLA Acceptance for Lunsumio VELO Combination
BASEL, Switzerland, June 18, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental...
sBLA
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ImmunityBio’s ANKTIVA Expansion Review Accepted by FDA
CULVER CITY, Calif., May 19, 2026 ImmunityBio announced that the U.S. Food and Drug Administration (FDA) has accepted its...
J&J Files FDA Application for IMAAVY in wAIHA
February 24, 2026 – Spring House, Pennsylvania, USA Johnson & Johnson has announced the submission of a supplemental Biologics...
FDA Accepts BioMarin’s PALYNZIQ sBLA for Priority Review in Adolescents with PKU
San Rafael, California — October 30, 2025 — BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration...
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