Leads Biolabs Secures Priority Review for Opamtistomig
NANJING, China | July 10, 2026 Nanjing Leads Biolabs Co., Ltd. has announced that the Center for Drug Evaluation...
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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...
Mesoblast Receives FDA BLA Filing Number for Rexlemestrocel-L
New York, USA & Melbourne, Australia, July 1, 2026 Mesoblast Limited announced that the U.S. Food and Drug Administration...
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...
Genentech Wins FDA Priority Review for Enspryng in Thyroid Eye Disease
SOUTH SAN FRANCISCO, Calif., June 29, 2026 Genentech, a member of the Roche Group, announced that the U.S. Food...
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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....
MoonLake Reports Strong Phase 3 Sonelokimab HS Results
ZUG, Switzerland, June 21, 2026 MoonLake Immunotherapeutics has announced compelling Week 52 results from its Phase 3 VELA clinical...
Moderna Gains FDA Panel Support for mRNA-1010 Flu Vaccine
CAMBRIDGE, Mass., June 20, 2026 Moderna, Inc. announced a major regulatory milestone for its investigational seasonal influenza vaccine mRNA-1010...
Inhibrx Wins FDA BLA Acceptance for Ozekibart in Chondrosarcoma
SAN DIEGO, June 15, 2026 Inhibrx Biosciences has achieved a major regulatory milestone with the U.S. Food and Drug...
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