Pharming Gains FDA Priority Review for Lower-Dose Joenja
LEIDEN, Netherlands — September 25, 2026 Pharming Group N.V. announced that the U.S. Food and Drug Administration (FDA) has...
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Insmed Wins FDA Priority Review for ARIKAYCE sNDA
Bridgewater, New Jersey, U.S., September 21, 2026 Insmed has announced that the U.S. Food and Drug Administration (FDA) has...
LEO Pharma Gains FDA Priority Review for Dersimelagon
BALLERUP, Denmark — September 18, 2026 LEO Pharma announced that the U.S. Food and Drug Administration (FDA) has accepted...
Capricor to Present Deramiocel HOPE-3 Data at WMS 2026
SAN DIEGO, Calif. — September 17, 2026 Capricor Therapeutics announced that 24-month data from the HOPE-3 Phase 3 trial...
PolarityBio Gains FDA Priority Review for SkinTE in DFUs
SALT LAKE CITY, Utah — September 15, 2026 PolarityBio announced that the U.S. Food and Drug Administration (FDA) has...
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Intellia Therapeutics Gains FDA Priority Review for Lonvo-z in HAE
CAMBRIDGE, Mass. — September 8, 2026 Intellia Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted...
Nicox Sets April 2027 FDA Decision Date for NCX 470
SOPHIA ANTIPOLIS, FRANCE, Aug 27, 2026 Nicox SA announced that the U.S. Food and Drug Administration (FDA) has accepted...
Senhwa Advances CX-5461 in Photoimmunotherapy Research
TAIWAN, August 12, 2026 Senhwa Biosciences, Inc. has announced new research findings involving its investigational cancer drug Pidnarulex (CX-5461),...
Belite Bio Wins FDA Priority Review for Tinlarebant NDA
SAN DIEGO, California, August 11, 2026 Belite Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has...
Scholar Rock Advances Apitegromab FDA Review with Second Fill-Finish Facility
CAMBRIDGE, Mass., August 7, 2026 Scholar Rock announced that the U.S. Food and Drug Administration (FDA) review of its...
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