FDA News

FDA Clears First-of-Kind Device to Treat Patients with Dialysis-Related Amyloidosis

US health regulators cleared use of a first-of-its-kind device to treat dialysis-related amyloidosis (DRA). The US Food and Drug Administration (FDA) authorized use of Lixelle Beta 2-microglobulin Apheresis Column under its pathway for medical devices that treat rare conditions. The device is used to treat DRA, a chronic, progressive condition …

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FDA Approves Astellas’ Cresemba for Rare but Serious Fungal Infections

The US Food and Drug Administration (FDA) has approved Astellas’ new antifungal drug to treat two rare, often fatal invasive fungal infections. The agency approved Astellas’ New Drug Application (NDA) for the use of Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in …

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FDA Approves Sandoz Zarxio as First Biosimilar in the US Market

Sandoz, a Novartis company, is the first company to receive approval of a biosimilar in the US through the new biosimilars pathway. The US Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz) for all indications included in the label of the reference product, Neupogen. Amgen’s Neupogen (filgrastim) was originally …

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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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