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ALKERMES: Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder

Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.

BECKMAN COULTER DIAGNOSTICS: Beckman Coulter's Access PCT Procalcitonin Assay receives U.S. FDA 510(k) clearance

The Access PCT strengthens industry's most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management

AMERICAN REGENT: Introduces FDA Approved Zinc Sulfate Injection, USP

American Regent, Inc. announced the introduction of FDA approved Zinc Sulfate Injection, USP.

LILLY: Receives FDA Priority Review for the Selpercatinib New Drug Application

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib (LOXO-292), for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

FDA Reporter