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Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne

Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne

AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for AMZEEQ (minocycline) topical foam, 4% for the treatment of moderate to severe acne. Previously known as FMX101, AMZEEQ has been indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne […]

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 […]

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Denovo Biopharma gets FDA approval to launch phase 2b GBM trial for DB102

Denovo Biopharma has secured approval from the US Food and Drug Administration (FDA) to launch its phase 2b clinical trial of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide. The GBM clinical study is an extension of the company’s work to identify a genetically-enriched patient population with diffuse large B-cell […]

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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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ProTom Radiance 330 proton therapy system bags FDA 510(k) Clearance

ProTom International has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiance 330 proton therapy system installed at the Massachusetts General Hospital (MGH) in Boston. According to the proton therapy technology manufacturer, the installed Radiance 330 proton therapy system is a compact, single-room system, which features an advanced pencil […]

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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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