FDA News

Oncolytics’ Reolysin Receives Orphan Drug Designation for Malignant Glioma

US health regulators granted orphan drug designation to Calgary-based Oncolytics Biotech’s lead brain tumor candidate. The company announced that the US Food and Drug Administration (FDA) granted orphan status to its Reolysin for treatment of malignant glioma. Oncolytics said that it had applied for orphan designation for pediatric high grade …

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FDA Asks Genervon to Release Complete Data from Controversial ALS Study

The US Food and Drug Administration (FDA) issued a statement calling on Genervon Biopharmaceuticals to release complete data from their recent trial evaluating an experimental drug for treatment of amyotrophic lateral sclerosis (ALS). The agency is prohibited by law from releasing confidential information about experimental drugs, however the agency requested …

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Sandoz Receives FDA Approval for the First Generic Version of Teva’s Multiple Sclerosis Drug Copaxone

Today, the US Food and Drug Administration (FDA) approved the first generic version of Teva Pharmaceuticals’ top-selling multiple sclerosis drug Copaxone (glatiramer acetate injection). The agency approved Sandoz’s Abbreviated New Drug Application (ANDA) for once daily Glatopa 20 mg/mL, a generic equivalent of daily Copaxone 20 mg. Glatopa is now …

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AstraZeneca’s Investigational Mesothelioma Drug Receives Orphan Drug Status from the FDA

US health regulators have granted Orphan Drug designation to AstraZeneca’s investigational drug in development for treatment of a rare cancer. AstraZeneca announced that the US Food and Drug Administration (FDA) has granted orphan status for its anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma. The agency provides orphan …

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MedImmune’s Respiratory Syncytial Virus Candidate Receives Fast Track Status from the FDA

Today, AstraZeneca’s biologics arm MedImmune announced that US health regulators have granted fast track designation for its respiratory syncytial virus (RSV) candidate. The company said that the US Food and Drug Administration (FDA) has granted Fast Track status for the development of MEDI8897, a high-potency, extended half-life monoclonal antibody (mAb). …

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Merck’s Hepatitis C Combo Receives Breakthrough Status for a New Patient Population

Today, Merck announced that its hepatitis C drugs have been designated breakthrough therapies by the US Food and Drug Administration (FDA). The news comes three months after the agency said that it would rescind breakthrough designation, due to the evolving hepatitis C treatment landscape and the introduction of competing drugs …

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