Invivyd Receives FDA EUA Termination Notice for PEMGARDA
NEW HAVEN, Conn., July 6, 2026 Invivyd announced that the U.S. Food and Drug Administration (FDA) has issued a...
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Opus Genetics Secures FDA Alignment for Phase 3 Trial
RESEARCH TRIANGLE PARK, N.C., July 6, 2026 Opus Genetics announced that the U.S. Food and Drug Administration (FDA) has...
DBV Technologies Works With FDA to Finalize VIASKIN Peanut BLA
CHÂTILLON, France, June 29, 2026 DBV Technologies announced an update on the Biologics License Application (BLA) for its investigational...
AbbVie Reports Positive Phase 3 Epcoritamab DLBCL Results
NORTH CHICAGO, Ill., June 29, 2026 AbbVie has announced positive topline results from the Phase 3 EPCORE® DLBCL-4 clinical...
FDA Selects Seven Firms for PreCheck Manufacturing Pilot
SILVER SPRING, Md., June 29, 2026 The U.S. Food and Drug Administration (FDA) has announced the selection of seven...
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Capricor Reaches Key FDA Milestone in DMD
SAN DIEGO, June 26, 2026 Capricor Therapeutics announced that the U.S. Food and Drug Administration (FDA) has scheduled a...
Sobi Receives FDA Complete Response Letter for NASP BLA
STOCKHOLM, Sweden, June 26, 2026 Sobi announced that it has received a Complete Response Letter (CRL) from the U.S....
Alvotech Announces FDA Acceptance of AVT16 Biosimilar Application for Entyvio
REYKJAVIK, Iceland, June 8, 2026 Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review...
Xbrane Nears FDA Decision for Lucamzi Biosimilar
STOCKHOLM, Sweden, June 3, 2026 Xbrane Biopharma AB has reached a significant regulatory milestone after the U.S. Food and...
Pierre Fabre Advances FDA Path for Tabelecleucel
SECAUCUS, N.J., May 7, 2026 Pierre Fabre Pharmaceuticals (PFP) announced a significant regulatory update following a Type A meeting...
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