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U.S. FDA

EOFlow Submits Application to the U.S. FDA for its Wearable Insulin Pump ‘EOPatch’

EOFlow Co., Ltd., a provider of wearable drug delivery systems (DDS), announced that it submitted a 510(k) application to the U.S. FDA for its...

Neurocrine Biosciences Announces U.S. FDA Accepts Supplemental New Drug Application

Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application...

Zhiyi Biotech Received Clinical Approval from U.S. FDA for SK10 in Chemotherapy-induced Diarrhea

Zhiyi Biotech announced that FDA has approved the Company's Investigational New Drug (IND) application to develop SK10 (Inactivated Bacteroides fragilis) for the treatment of...

AnBogen Therapeutics Receives Approval from U.S. FDA for Phase Ib/II Protocol Amendment for ABT-101

AnBogen Therapeutics, a clinical-stage biotech company designing and developing precision oncology therapies to improve the life of patients, announces that U.S. Food and Drug...

U.S. FDA Approves Additional Indication of Darolutamide in Combination With Docetaxel

Orion’s collaboration partner Bayer announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen...
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