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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 […]

Alcon launches PanOptix trifocal intraocular lens for cataract patients in US

Alcon has commercially launched AcrySof IQ PanOptix trifocal intraocular lens (IOL) in the US after its approval by the US Food and Drug Administration (FDA). PanOptix is said to be the first trifocal lens to be approved by the FDA for patients undergoing cataract surgery in the US. The FDA approval was based on data […]

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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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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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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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Boehringer Ingelheim bags Ofev FDA approval for SSc-ILD

Ofev FDA approval for SSc-ILD : The US Food and Drug Administration (FDA) has extended approval for Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) capsules for the treatment of a particular condition associated with systemic sclerosis or scleroderma. The latest FDA approval for Ofev is for its use in slowing the rate of decline in pulmonary function […]

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Kyowa Kirin’s Nourianz cleared for use in Parkinson’s disease in US

Nourianz FDA approval : The US Food and Drug Administration (FDA) has cleared Kyowa Kirin’s Nourianz (istradefylline) for adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes. Orally administered Nourianz is claimed to be the first and only Adenosine A2A receptor antagonist for use in Parkinson’s disease in the US. […]

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Celgene bags Inrebic FDA approval for myelofibrosis

Inrebic FDA approval : Celgene’s subsidiary Impact Biomedicines, has bagged approval for its oral kinase inhibitor Inrebic (fedratinib) capsules from the US Food and Drug Administration (FDA) for the treatment of certain types of myelofibrosis, a rare bone marrow cancer. Fedratinib FDA approval is for the treatment of adult patients with intermediate-2 or high-risk primary […]

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AbbVie secures Rinvoq FDA approval for rheumatoid arthritis

Rinvoq FDA approval : US biopharma company AbbVie has bagged approval from the US Food and Drug Administration (FDA) for its 15mg, daily once oral, small molecule Janus kinase (JAK) inhibitor – Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis (RA). The FDA approval for Rinvoq is for the treatment of […]

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