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),...
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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...
Praxis Precision Medicines Advances Key Regulatory Programs
BOSTON, August 6, 2026 Praxis Precision Medicines reported its second quarter 2026 financial results, highlighting continued regulatory progress for...
Merck FDA Accepts ENFLONSIA sBLA for Second RSV Season
RAHWAY, N.J., August 6, 2026 Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental...
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ITM Launches Lumara Bio to Advance Radiopharmaceutical Oncology Pipeline
Garching/Munich, Germany and Princeton, New Jersey – July 27, 2026 ITM Isotope Technologies Munich SE (ITM) has launched Lumara...
BridgeBio Announces FDA Acceptance of Encaleret NDA for ADH1
PALO ALTO, Calif., July 22, 2026 BridgeBio has reached a significant regulatory milestone after the U.S. Food and Drug...
Dyne Therapeutics Advances DMD Program with FDA Acceptance
WALTHAM, Mass., July 20, 2026 Dyne Therapeutics, Inc. (Nasdaq: DYN) announced that the U.S. Food and Drug Administration (FDA)...
Camurus NDA Resubmission for CAM2029 Accepted by FDA
LUND, Sweden, July 17, 2026 Camurus announced that the U.S. Food and Drug Administration (FDA) has accepted for review...
Apnimed Targets First Oral Sleep Apnea Therapy with FDA NDA
CAMBRIDGE, Mass., July 14, 2026 Apnimed, Inc. has achieved a significant regulatory milestone after the U.S. Food and Drug...
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