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...
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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...
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)...
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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...
Arcutis FDA Accepts ZORYVE sNDA for Infant Dermatitis
WESTLAKE VILLAGE, Calif., July 8, 2026 Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted...
Praxis and Remagine Collaborate on Ulixacaltamide
BOSTON, Mass. and AUSTIN, Texas, July 7, 2026 Praxis Precision Medicines and Remagine Labs have entered into a strategic...
Pharvaris Advances Oral HAE Therapy with FDA NDA Acceptance
ZUG, Switzerland, July 6, 2026 Pharvaris announced that the U.S. Food and Drug Administration (FDA) has accepted the New...
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