Organon’s MIUDELLA FDA Review Advances Hormone-Free IUD
Jersey City, New Jersey, September 15, 2026 Organon has announced that the U.S. Food and Drug Administration (FDA) has...
FDA review
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Insight Molecular Diagnostics Advances GraftAssureDx FDA Review
NASHVILLE, Tennessee, August 10, 2026 Insight Molecular Diagnostics, Inc. (iMDx) reported second-quarter 2026 results and provided an update on...
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...
Corcept Resubmits Relacorilant NDA for Cushing’s Syndrome to FDA
REDWOOD CITY, Calif., June 17, 2026 Corcept Therapeutics Incorporated announced the resubmission of its New Drug Application (NDA) to...
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SK Life Science NDA for Cenobamate Suspension Accepted
PARAMUS, N.J., June 15, 2026 SK Life Science, Inc. has announced that the U.S. Food and Drug Administration (FDA)...
Moderna Publishes Positive Phase 3 Clinical Data for mRNA-1010 Seasonal Influenza Vaccine in New England Journal of Medicine
CAMBRIDGE, Mass., May 6, 2026 Moderna announced the publication of pivotal Phase 3 clinical safety and efficacy data for...
Gilead to Acquire Arcellx in $7.8B Cell Therapy Deal
February 24, 2026 — Foster City, CA & Redwood City, CA:Gilead Sciences, Inc. (Nasdaq: GILD) today revealed a definitive...
Corify Unveils First Whole-Heart Mapping in a Single Beat
Madrid | January 28, 2026 — Corify Care, a cardiovascular MedTech innovator, announced a major advancement in cardiac electrophysiology...
FDA Advances Tradipitant Review for Motion Sickness Relief
Washington, D.C., November 28, 2025 In a significant regulatory development, Vanda Pharmaceuticals Inc. has announced major progress on tradipitant,...
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