FDA News

FDA Grants Early Approval to Bristol-Myers Squibb’s Opdivo for Lung Cancer

The US Food and Drug Administration (FDA) expanded approval of Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) to treat patients with advanced squamous non-small cell lung cancer (NSCLC). The approval comes just days after the agency accepted BMS’ application and granted the drug priority review. The FDA was scheduled to make a …

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Oncolytics’ Reolysin Receives Orphan Drug Designations from the FDA

Oncolytics Biotech Inc.’s lead product candidate Reolysin was granted orphan drug designation for two types of cancer this week. The company announced Monday that the US Food and Drug Administration (FDA) granted the drug orphan drug designation for Reolysin for the treatment of cancer of the fallopian tube. On Tuesday, …

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FDA Grants Priority Review to Bristol-Myers Squibb’s PD-1 Inhibitor for Treatment of Lung Cancer

US health regulators have accepted, and granted Priority Review, for Bristol-Myers Squibb Company’s (BMS) lung cancer drug. BMS announced that the US Food and Drug Administration (FDA) has accepted for filing and review the Biologics License Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small …

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FDA Grants Breakthrough Therapy Status to Atara and MSK’s T Cell Therapy

Atara Biotherapeutics, Inc. and partner Memorial Sloan Kettering Cancer Center (MSK) announced that they have received Breakthrough Therapy designation for its promising T cell therapy. The companies said that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Atara’s optioned cytotoxic T lymphocytes activated against Epstein-Barr Virus …

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Ignyta’s Lung Cancer Drug Receives Orphan Drug Status from the FDA

Today, precision oncology biotechnology company Ignyta, Inc. announced that its lead candidate has been granted orphan drug designation from US health regulators. According to the company, the US Food and Drug Administration (FDA) granted Ignyta’s entrectinib orphan drug designation for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small …

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