Closure of the post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis

21 December 2020 - A plain language summary for the post-market review of the use of biologics in the treatment ...

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Lung cancer drug subsidy will make 'big difference' for patients

20 December 2020 - If you’re a non-smoking woman and you develop a cough, the last thing you think you've ...

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Karyopharm announces FDA approval of Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior therapy

18 December 2020 - Oral Xpovio now available as a treatment option for patients with multiple myeloma as early as first ...

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FDA approves first adjuvant therapy for most common type of lung cancer

18 December 2020 - Today, the U.S. FDA approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell ...

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Medicines for hepatitis C remain in the high-cost protection after TLV's reconsideration

18 December 2020 - During the autumn, the Swedish Dental and Pharmaceutical Benefits Agency, TLV, reconsidered the subsidy of the hepatitis ...

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FDA approves first oral hormone therapy for treating advanced prostate cancer

18 December 2020 - Today, the U.S. FDA approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. ...

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Novaremed receives fast track designation from the FDA for NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy

18 December 2020 - Novaremed announced today that it has received fast track designation from the U.S. FDA for the development ...

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Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2.4 mg for weight management

18 December 2020 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for subcutaneous semaglutide ...

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Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of advanced systemic mastocytosis

17 December 2020 - Blueprint Medicines today announced the submission of a supplemental new drug application to the U.S. Food FDA ...

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Recommendations made by the PBAC - November 2020

18 December 2020 - The recommendations from the November 2020 PBAC meeting are now available. ...

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Report on the collection of under co-payment data 2019-20

18 December 2020 - The report on the collection of under co-payment data 2019-20 is now available. ...

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Sandoz Canada receives authorisation from Health Canada to launch new biosimilar Hyrimoz (adalimumab)

17 December 2020 - Hyrimoz approved for use in all same indications as reference medicine* including rheumatology, gastro-enterology and dermatology. ...

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FDA approves Amgen's Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab)

17 December 2020 - Fifth FDA Approval From Amgen's Biosimilars Portfolio. ...

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Novartis investigational oral therapy iptacopan (LNP023) receives FDA breakthrough therapy designation for PNH and rare paediatric disease designation for C3G

16 December 2020 - Iptacopan is in development for paroxysmal nocturnal haemoglobinuria, as well as C3 glomerulopathy and several other ...

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Decibel Therapeutics announces DB-020 has been granted fast track designation by the U.S. FDA

17 December 2020 - Decibel Therapeutics today announced that their clinical product candidate, DB-020, has been granted fast track designation ...

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