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FDA Postpones Advisory Meeting on Biosimilar Copy of Remicade

The US Food and Drug Administration (FDA) has postponed an advisory committee meeting to consider approval of Hospira and partner Celltrion’s biosimilar of Remicade. The agency said that it wants more time to review the Biologics License Application (BLA) for CT-P13, a proposed biosimilar to Janssen Biotech Inc.’s Remicade (infliximab), …

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FDA Grants Oncolytics’ Pancreatic Cancer Drug Orphan Drug Designation

Today, Oncolytics Biotech Inc. announced that its lead pancreatic cancer drug was granted orphan drug designation by US health regulators. The company said that its lead product candidate, Reolysin, was granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The agency provides …

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FDA Expands Approval of Eisai’s Banzel for Pediatric Patients Ages 1-4

Eisai Inc. announced that US health regulators expanded approval of Banzel (rufinamide) as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients. The company said that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Banzel for treatment of …

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Eisai’s Thyroid Cancer Drug Receives Early FDA Approval

The US Food and Drug Administration (FDA) has granted an early approval to Eisai’s drug for the most common form of thyroid cancer. The agency announced that it has approved the Japanese drugmaker’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive …

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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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Pfizer’s Breast Cancer Drug Receives Accelerated Approval from the FDA

Federal health regulators have provided an early approval to Pfizer Inc.’s Breakthrough breast cancer drug palbociclib. The company announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Ibrance (palbociclib) in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth …

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FDA Approves Glyxambi for Patients with Type 2 Diabetes

US health regulators have approved a first-of-its-kind diabetes treatment, which combines two existing drugs in one tablet. The US Food and Drug Administration (FDA) has approved Eli Lilly and Co and Boehringer Ingelheim Pharmaceuticals’ Glyxambi (empagliflozin/linagliptin) tablets, as an adjunct to diet and exercise to improve glycemic control in adults …

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Genentech’s Investigational Monoclonal Antibody Granted Breakthrough Status for Treatment of Lung Cancer

US-based Genentech recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational cancer immunotherapy. The agency granted the designation to Genentech’s MPDL3280A for treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during …

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