Biogen cuts price for Alzheimer’s drug Aduhelm by half

20 December 2021 - The drug has sold poorly since its approval in June due to concerns about its safety, effectiveness ...

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NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma

17 December 2021 - The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund. ...

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EMA recommends Nuvaxovid for authorisation in the EU

20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...

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EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency

17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...

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Edenbridge Pharmaceuticals announces U.S. FDA approval of Dartisla ODT (glycopyrrolate) orally disintegrating tablets

17 December 2021 - First and only orally disintegrating tablet of glycopyrrolate. ...

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Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus

20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...

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CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults

17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...

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New treatment for heart failure to support thousands of Australian patients

20 December 2021 - From 1 January 2022, tens of thousands of Australians with symptomatic heart failure will have access to ...

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PHARMAC’s year in review

20 December 2021 - Today PHARMAC has released its Year in Review for 2021, an annual publication highlighting key aspects of ...

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Injectafer (ferric carboxymaltose injection) receives FDA approval for the treatment of paediatric patients with iron deficiency anaemia

15 December 2021 - For patients as young as one year of age who have intolerance to, or have had ...

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FDA approves Telix’s prostate cancer imaging product, Illuccix

19 December 2021 - Telix Pharmaceuticals today announces that the United States FDA has approved Telix’s lead prostate cancer imaging product, ...

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Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) as first-line treatment for ALK positive advanced lung cancer

17 December 2021 - Recommendation based on results from the Phase 3 CROWN trial, which showed Lorviqua reduced the risk of ...

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Xalud Therapeutics receives FDA fast track designation for XT-150 for the treatment of pain associated with osteoarthritis of the knee

17 December 2021 - Xalud Therapeutics announced today that the United States FDA has granted fast track designation to the Company’s ...

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Novavax announces submission of new drug application in Japan for approval of COVID-19 vaccine

15 December 2021 - Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for new drug application, to Japan's ...

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Fist Assist Devices receives FDA “breakthrough device” designation for the world’s first wearable vein dilation device for ESRD patients

16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...

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