FDA News

FDA Accepts ArmaGen’s IND for its Hurler Syndrome Candidate

Privately-held biotech ArmaGen, Inc. announced today that US health regulators have accepted for review its investigational New Drug (IND) application for its drug for a rare lysosomal storage disease. The company, focused on developing novel therapies to treat severe neurological disorders, said that the US Food and Drug Administration (FDA) …

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Clovis Oncology’s Ovarian Cancer Candidate Wins Breakthrough Status from the FDA

Colorado-based Clovis Oncology, Inc. announced that US health regulators granted Breakthrough Therapy designation to its ovarian cancer candidate, sending shares up nearly nine percent in after-hours Monday. The company said that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational PARP inhibitor, rucaparib, as …

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FDA Grants Orphan Drug Status to Curis’ Blood Cancer Candidate

The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Curis’ blood cancer candidate. The cancer biotech company announced today that the agency granted Orphan Drug designation to its lead proprietary drug candidate, CUDC-907, for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). The agency grants orphan …

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Actavis Seeks US Approval to Market Generic Version of Gilead’s PAH Drug

Dublin-based Actavis PLC said Friday that it is seeking approval from the US Food and Drug Administration (FDA) to sell a generic version of Gilead Sciences Inc.’s pulmonary arterial hypertension (PAH) drug. The company confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the agency seeking approval …

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Hospira Presents Data Demonstrating the Biosimilarity Between Amgen’s Epogen and Hospira’s Proposed Biosimilar

Hospira, Inc. presented two studies supporting biosimilar application for Epoetin Hospira in the US. Hospira, a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, presented two studies at the National Kidney Foundation (NKF) Spring Meeting. The two presentations were “PK/PD Equivalence of Epoetin …

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Novo Nordisk Announces Plans to Resubmit Rejected Insulin to the FDA

Novo Nordisk A/S announced its decision to resubmit its marketing applications for diabetes drugs Tresiba and Ryzodeg to US health regulators. In 2013, the company submitted marketing applications to the US Food and Drug Administration (FDA) for basal insulin product Tresiba and combination therapy Ryzodeg. Even after an advisory committee …

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FDA Issues Warning of Life-Threatening Effect When Combining A Heart Drug with New Hepatitis C Drugs

The US Food and Drug Administration (FDA) issued a warning about the risk of potentially life-threatening slowing of the heart rate that can occur when a common heart drug is taken with new hepatitis C medications. The agency said that this complication can occur when the antiarrhythmic drug amiodarone is …

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FDA Expands Approval of Regeneron’s Eylea for Diabetic Retinopathy in Patients with Diabetic Macular Edema

The US Food and Drug Administration (FDA) has expanded approval of Regeneron’s macular degeneration drug for treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The agency’s approval of Regeneron Pharmaceuticals’ Eylea (afilibercept) injection for treatment of diabetic retinopathy (DR) in patients with DME marks the fourth approval …

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