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...
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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...
Ocugen Completes Dosing in Phase 2/3 Stargardt Trial
MALVERN, Pa., USA — April 1, 2026 Ocugen, Inc. has announced the early completion of dosing in its Phase...
AbbVie Submits BLA for Pivekimab Sunirine to FDA for Rare Blood Cancer
North Chicago, IL – September 30, 2025 – AbbVie (NYSE: ABBV) announced the submission of a Biologics License Application...
Novo Nordisk Submits BLA for Mim8, Offering Flexible Hemophilia A Prophylaxis
Bagsværd, Denmark & Plainsboro, N.J., September 29, 2025 – Novo Nordisk has formally submitted a Biologics License Application (BLA)...
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