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...
BLA
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Nanoscope’s MOGENRY BLA Accepted by FDA for Retinitis Pigmentosa
Dallas, Texas, USA, September 9, 2026 Nanoscope Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has...
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...
BridgeBio to Present New Infigratinib Data in Achondroplasia
PALO ALTO, Calif., September 2, 2026 BridgeBio Pharma, Inc. announced plans to present new clinical data on the impact...
uniQure Submits BLA for AMT-130 in Huntington’s Disease
LEXINGTON, Mass. and AMSTERDAM, September 2, 2026 uniQure N.V. announced the submission of a Biologics License Application (BLA) to...
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Alvotech Wins FDA Review Acceptance for AVT80 Biosimilar
Reykjavik, Iceland – August 31, 2026 Alvotech announced that the U.S. FDA has accepted for review its Biologics License...
Capricor Advances Deramiocel as FDA Review Continues
SAN DIEGO, August 13, 2026 Capricor Therapeutics continues to advance Deramiocel (CAP-1002) for Duchenne muscular dystrophy (DMD) as the...
PTC Therapeutics to Acquire ST-920 Fabry Gene Therapy Program
Warren, New Jersey, August 12, 2026 PTC Therapeutics announced that it was selected as the winning bidder to acquire...
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...
Seaport Therapeutics Reports Q2 Progress Across Neuropsychiatry Pipeline
BOSTON, Aug. 3, 2026 Seaport Therapeutics, Inc. reported its second-quarter 2026 financial results while highlighting continued progress across its...
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