FDA Cracks Down on Illegal Tobacco Product Sales
SILVER SPRING, Md., May 20, 2026 The U.S. Food and Drug Administration (FDA) has intensified its enforcement efforts against...
Regulatory Affairs
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Dark Horse Consulting and KunTuo Partner to Accelerate CGT Trials
WALNUT CREEK, Calif., and BEIJING, China, May 11, 2026 Dark Horse Consulting Group (DHCG) and KunTuo Medical Research and...
FDA CRL Delays Bitopertin Approval for Rare EPP Disease
WATERTOWN, Mass., Feb. 13, 2026 — Disc Medicine announced that the U.S. Food and Drug Administration has issued a...
FDA Expands Yescarta Label in CNS Lymphoma Care
Santa Monica, California — February 6, 2026 Kite, a Gilead Company, has announced that the U.S. Food and Drug...
Immusoft Earns FDA Rare Pediatric Disease Status for ISP-002
SAN FRANCISCO, CALIFORNIA | January 26, 2026 — Immusoft, a clinical-stage biotechnology company pioneering engineered B cell therapies, announced...
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Merz Submits EMA Application for Pediatric XEOMIN Spasticity Use
FRANKFURT AM MAIN, GERMANY | January 26, 2026 — Merz Therapeutics has completed and submitted a regulatory application to...
EMA Validates ENHERTU Combo for First-Line HER2 Breast Cancer
TOKYO and MUNICH | January 19, 2026 — Daiichi Sankyo and AstraZeneca announced that the European Medicines Agency (EMA)...
Nxera Reports Positive Phase 3 Results for Daridorexant
TOKYO, Japan and CAMBRIDGE, United Kingdom | January 19, 2026 — Nxera Pharma Co., Ltd. announced positive top-line results...
FDA Food Registration Expands Farmmi’s U.S. Supply Chain
LISHUI, China, January 14, 2026 — Farmmi, Inc. announced that its U.S. subsidiary, Suppchains Group Inc., has successfully completed...
FDA Approves RHA® Dynamic Volume for Midface Contour Deficits
Nashville, Tenn., January 13, 2026 — Revance and Teoxane announced that the U.S. Food and Drug Administration has approved...
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