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  • Lilly launches Humalog Junior KwikPen

    INDIANAPOLIS — Eli Lilly’s latest introduction is making half-unit doses of insulin easier for patients with Type 1 and Type 2 diabetes. The company on Wednesday launched its Humalog Junior KwikPen, which it said is the only prefilled, disposable half-unit insulin pen. The Food and Drug Administration approved the product in June to treat diabetes.

  • FDA approves Novo Nordisk’s Fiasp fast-acting insulin

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new fast-acting mealtime insulin from Novo Nordisk. The agency granted approval to Fiasp to treat adults with diabetes.

    The drug is a formulation featuring the company’s NovoLog insulin aspart developed with the aim of achieving properties that more closely match the natural physiological insulin mealtime response of someone without diabetes.

  • FDA approves Lilly’s breast cancer drug Verzenio

    SILVER SPRING, Md. — Eli Lilly’s new treatment for certain breast cancers has been approved by the Food and Drug Administration. Verzenio (abemaciclib) was approved to as a treatment for patients with a hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that is advanced or metastatic and has progressed following endocrine therapy.

  • Merck gets FDA approval for new Keytruda indication

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Keytruda (pembrolizumab), the drug’s manufacturer Merck announced recently. The drug is now approved as a third-line treatment for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors test positive for a certain protein identified by an FDA-approved test.

  • Foundation Consumer Healthcare among buyers of Teva’s women’s health brands

    JERUSALEM — Teva has made two separate sales from its global women’s health business in an effort to repay term loan debt. The move follows its sale last week of its Paragard IUD.

  • FDA approves Symbiomix Therapeutics’ Solosec
    SILVER SPRING, Md. — The Food and Drug Administration has approved Symbiomix Therapeutics’ new drug Solosec (secnidazole) oral granules. The drug is the first approved single-dose oral therapy for bacterial vaginosis. 
     

  • AAM unveils push for CREATES Act passage

    WASHINGTON — The Association for Accessible Medicines has rolled out a new video and infographic in support of its campaign for patients to call on their representatives to support legislation supporting the generics industry. The materials outline AAM’s case for passing the Creating and Resorting Equal Access to Equivalent Samples Act.

  • AARP highlights rising specialty prices as FDA looks to tackle development costs, speed

    The price of drugs — particularly specialty drugs — is the perennial issue plaguing both patients and the companies that make them, as the cost of making a drug, estimated at around $2.6 billion with an average time of 10-15 years, will be factored into the cost of a treatment. Recently, though, patient advocates and regulators have begun acknowledging a need for something to be done about this trend.

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