Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C

18 June 2021 - Orphazyme today announced it has received a complete response letter from the U.S. FDA following its ...

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Outcomes of the May 2021 PBAC intracycle meeting

18 June 2021 - The outcomes from the May 2021 PBAC meeting are now available. ...

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Dupixent (dupilumab) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases

17 June 2021 - The pre-filled pen offers an additional administration option for all Dupixent indications in patients aged 12 years ...

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FDA approves a nasal anti-histamine for non-prescription use

17 June 2021 - The U.S. FDA today approved a nasal antihistamine for nonprescription use through a process called a partial ...

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Ontozry scores MHRA authorisation for focal-onset seizures

17 June 2021 - The MHRA has granted Arvelle Therapeutics’ Ontozry a marketing authorisation for the adjunctive treatment of focal-onset ...

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FDA approves avapritinib for advanced systemic mastocytosis

16 June 2021 - On June 16, 2021, the FDA approved avapritinib (Ayvakit, Blueprint Medicines) for adult patients with advanced ...

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FDA approves StrataGraft for the treatment of adults with thermal burns

15 June 2021 - Today, the U.S. FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact ...

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Eton Pharmaceuticals announces FDA approval of Rezipres (ephedrine hydrochloride injection)

15 June 2021 - Eton Pharmaceuticals today announced that the U.S. FDA has approved Rezipres (ephedrine hydrochloride injection) for the treatment ...

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Medtronic announces FDA approval of its next generation recharge-free spinal cord stimulation platform

10 June 2021 - Vanta implantable neurostimulator offers up to 11 year battery life and personalised pain relief. ...

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Avenue Therapeutics receives complete response letter from the FDA for intravenous tramadol

14 June 2021 - Avenue Therapeutics today announced that it has received a second complete response letter from the U.S. ...

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Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S

11 June 2021 - The U.S. FDA has issued a complete response letter regarding the supplemental new drug application for ...

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Delytact oncolytic virus G47∆ approved in Japan for treatment of patients with malignant glioma

10 June 2021 - First oncolytic virus ever approved for treatment of malignant glioma or any primary brain cancer. ...

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Health Canada grants interim order authorisation for casirivimab and imdevimab for the treatment of mild to moderate COVID-19

10 June 2021 - Interim data shows treatment with casirivimab and imdevimab resulted in a statistically significant reduction in viral ...

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Astellas’ Xtandi bags NICE approval in prostate cancer

10 June 2021 - Astellas’ oral treatment Xtandi has received approval from NICE for the treatment of metastatic hormone-sensitive prostate ...

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NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis

10 June 2021 - Around 25,000 people with moderate rheumatoid arthritis that has not responded to conventional therapies are set to ...

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