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Healthcare solutions provider, Novartis, has announced that the European Commission has approved its combination therapy, Tafinlar + Mekinist, for adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma. Read more

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The European Commission (EC) has granted a marketing authorisation for the oral receptor tyrosine kinase (RTK) inhibitor, LENVIMA (lenvatinib mesylate), as first-line treatment for adults with advanced or unresectable hepatocellular carcinoma (HCC). Read more

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The US Food and Drug Administration (FDA) has approved the first RNA-based therapy for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Read more

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The European Commission (EC) has approved Novartis’ Aimovig (erenumab) for the prevention of migraine in adults experiencing four or more migraines per month. Read more

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The US Food and Drug Administration (FDA) has approved the first drug indicated to treat smallpox — TPOXX (tecovirimat) — to SIGA Technologies. Read more

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Two drugs, to be administered together for the treatment of ATC that cannot be surgically removed or has spread and has a type of abnormal gene, BRAF V600E, Tafinlar (dabrafenib) and Mekinist (trametinib), have been approved by the FDA Read more

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Swiss-based healthcare company, Novartis, has revealed that the US Food and Drug Administration (FDA) has approved its CAR-T therapy, Kymriah, for its second distinct indication. Read more

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The first allogenic stem cell therapy — Alofisel (darvadstrocel) from TiGenix and Takeda Pharmaceutical Company — has received marketing authorisation approval from the EC for the treatment of complex perianal fistulas in Crohn’s disease Read more

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The US Food and Drug Administration (FDA) has approved Addmedica’s drug Siklos (hydroxyurea tablets) for the treatment of paediatric patients, two years of age and older, suffering from sickle cell anaemia. Read more

Technology

The advisory committee of the US Food and Drug Administration (FDA) has recommended the approval of Braeburn Pharmaceutical’s investigational buprenorphine depot, CAM2038, for the treatment of opioid use disorder. Read more

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Global pharmaceutical company, Mylan, has announced that its partner Synthon has received European marketing authorisation approval for its generic, Glatiramer Acetate injection, to treat patients with relapsing forms of multiple sclerosis (MS). Read more

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Novartis has received approval for its chimeric antigen receptor T cell (CAR-T) therapy, Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, from the US Food and Drug Administration (FDA). Read more

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The European Commission (EC) has approved Samsung Bioepis’ Imraldi — a biosimilar referencing adalimumab (Humira) — for the treatment of 10 inflammatory conditions. Read more

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The US Food and Drug Administration (FDA) has approved Haegarda, which is the first C1 Esterase Inhibitor (human) for subcutaneous (under the skin) administration in the prevention of hereditary angioedema (HAE) attacks Read more

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