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Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients

Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients

Xarelto FDA approval : The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) for the prevention of venous thromboembolism or blood clots in acutely ill medical patients. The latest approval for the drug is for the treatment of blood clots in hospitalized […]

Lilly bags Reyvow FDA approval for acute treatment of migraine

Reyvow FDA approval : Eli Lilly and Company (Lilly) has bagged approval from the US Food and Drug Administration (FDA) for Reyvow (lasmiditan) for the acute treatment of migraine, irrespective of aura (a sensory phenomenon or visual disturbance), in adults. The oral treatment, which has been designed to bind to 5-HT1F receptors with high affinity, […]

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Novartis bags Beovu FDA approval for wet AMD

Beovu FDA approval for wet AMD : Swiss pharma giant Novartis has been given approval from the US Food and Drug Administration (FDA) for Beovu (brolucizumab) injection for wet age-related macular degeneration (AMD). Also called RTH258, Beovu is now the first FDA approved anti-VEGF which is said to deliver greater fluid resolution compared to aflibercept. […]

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Verastem gets FDA orphan drug status for COPIKTRA for T-Cell lymphoma

Verastem Oncology has secured orphan drug designation for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), from the US Food and Drug Administration (FDA) for the treatment of T-Cell lymphoma. COPIKTRA has FDA approval for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following more than two prior therapies. The PI3K also has […]

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FDA approves AstraZeneca’s FASENRA self-administration via FASENRA Pen

AstraZeneca has bagged approval from the US Food and Drug Administration (FDA) for the self-administration of FASENRA (benralizumab) through FASENRA Pen, a pre-filled, single-use auto-injector, for the add-on maintenance treatment of severe asthma in patients aged 12 years and older, and with an eosinophilic phenotype. FASENRA is a monoclonal antibody which directly binds to the […]

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Annexon gets FDA fast track status for ANX005 in Guillain-Barré Syndrome

Annexon Biosciences has bagged the fast track designation for its C1q inhibitor ANX005 from the US Food and Drug Administration (FDA) for the treatment of Guillain-Barré Syndrome (GBS). Considered to be a rare, acute, antibody-mediated autoimmune disease, Guillain-Barré Syndrome affects the peripheral nervous system for which there are no approved therapies in the US till […]

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Novo Nordisk bags Rybelsus FDA approval for type 2 diabetes

Rybelsus FDA approval : Danish pharma company Novo Nordisk has bagged approval from the US Food and Drug Administration (FDA) for Rybelsus (semaglutide) oral tablets for its use in patients with type 2 diabetes. The FDA approval for Rybelsus is to improve control of blood sugar in addition to diet and exercise in adults having […]

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Sound Pharmaceuticals bags FDA fast track status for SPI-1005 in Meniere’s Disease

US biopharma company Sound Pharmaceuticals said that its investigational drug SPI-1005 has secured the fast track designation (FTD) from the US Food and Drug Administration (FDA) for the treatment of Meniere’s Disease (MD), a disorder of the inner ear. The FTD was granted by the FTD’s Division of Neurology Products, which is for drugs that can […]

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Genentech bags Rozlytrek FDA approval for two rare types of cancer

Rozlytrek FDA approval : Roche’s subsidiary Genentech has bagged approvals for Rozlytrek (entrectinib) from the US Food and Drug Administration (FDA) for a type of non-small cell lung cancer (NSCLC) and for certain forms of solid tumors. The first Rozlytrek FDA approval is for the treatment of ROS1-positive, metastatic NSCLC in adult patients. Additionally, Rozlytrek […]

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GSK bags Nucala FDA approval for severe eosinophilic asthma in 6-11 years age group

Nucala FDA approval : GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for Nucala (mepolizumab) for the treatment of severe eosinophilic asthma in children, aged six years and older. Nucala, which is a monoclonal antibody that targets IL-5, is now the only targeted biologic to be approved by the FDA […]

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