European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis

28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...

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Health products portal – intent to apply

14 November 2019 - The Department of Health (the Department) has been working to digitise and simplify the PBS submission ...

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Application process changes for access to Section 100 - Highly Specialised Drugs medicines

25 July 2019 - From 1 August 2019, hospital authorities will no longer be required to seek separate approval from ...

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PHARMAC publishes list of applications to be considered by PTAC later this month

14 May 2019 - The list includes a number of medicines for patients with breast cancer. ...

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Bayer completes rolling submission for darolutamide in U.S.

27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...

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PBAC - 2018 in review

7 January 2019 - The PBAC considered 195 submissions in 2018; 173 were considered by the PBAC in 2017. ...

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Treatment for families battling a devastating rare disease

3 May 2018 - New Zealand infants suffering from a rare neuromuscular condition may soon be eligible for compassionate access ...

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CADTH Common Drug Review will accept submissions up to six months pre-Notice of Compliance

8 March 2018 - Operational change can help reduce the time between regulatory approval and reimbursement recommendations for prescription drugs ...

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Industry fees are applicable to all CDR resubmissions

13 November 2017 - All resubmissions that are filed by manufacturers on or after 2 January 2018 will be subject to ...

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Revised procedure for the CADTH Common Drug Review resubmissions

13 November 2017 - In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements ...

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Sunovion announces FDA acceptance for review of new drug application for dasotraline for the treatment of ADHD

10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application ...

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FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in the treatment of ADPKD

9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program ...

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Company statement on resubmission of biosimilar trastuzumab and pegfilgrastim dossiers with EMA

7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...

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GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease

 7 November 2017 - GlaxoSmithKline today announced the submission of a supplemental biologics license application to the United States FDA, ...

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Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency

6 November 2017 - The application for marketing approval is based on the COMPASS study. ...

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