FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukaemia

20 May 2022 - Today the FDA approved azacitidine (Vidaza, Celgene) for paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia. ...

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People dying of COVID while life-saving drugs go unused, doctors say

21 May 2022 - Top doctors have warned that vulnerable patients who test positive to COVID-19 are missing out on ...

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CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD

20 May 2022 - Recommendation based on positive results from two clinical trials in which Xenpozyme provided improvement across multiple non-CNS ...

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Karyopharm and Menarini Group receive positive CHMP opinion for Nexpovio (selinexor) for the treatment of patients with refractory multiple myeloma

20 May 2022 - European Commission decision anticipated within approximately 60 days. ...

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Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions

20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...

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FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder

20 May 2022 - Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis in adults and ...

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CHMP recommends approval of Lilly and Incyte's Olumiant (baricitinib) as the first and only centrally authorised treatment for adults with severe alopecia areata

20 May 2022 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for ...

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AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease

20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...

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Highlights from the 16-19 May 2022 CHMP meeting

20 May 2022 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. ...

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Lumasiran for treating primary hyperoxaluria type 1

20 May 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using lumasiran ...

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Mirati Therapeutics submits marketing authorisation application to the European Medicines Agency for investigational adagrasib as a treatment for previously treated KRASG12C mutated non-small-cell lung cancer

19 May 2022 - Submission follows the U.S. FDA acceptance of the adagrasib new drug application for the same indication ...

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Medicines Australia puts spotlight on reform priority for the next Government

20 May 2022 - Medicines Australia has set the scene for major health reform by the next Government by alerting ...

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Plea to make new depression 'spray' affordable

19 May 2022 - Mental health experts say a nasal spray to help relieve depression should be subsidised to make ...

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Major parties committed to major medicines policy reform and reviews – whoever wins on Saturday

19 May 2022 - Medicines Australia has been assured in official communications from the respective Campaign Headquarters that both the ...

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BMS’ Sprycel reimbursement criteria to be broadened for paediatric Philadelphia chromosome positive ALL

19 May 2022 - The state health insurance review agency said it would broaden the reimbursement criteria for Sprycel (dasatinib), ...

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