EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

7 May 2025 - The vaccine must not be used in people 65 years and above while review is underway. ...

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Authorisations of human medicinal products with a new active substance and additional indications 2024

28 February 2025 - 46 human medicinal products with new active substances authorised. ...

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Human medicines in 2024

16 January 2025 - In 2024, EMA recommended 114 medicines for marketing authorisation.  ...

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Utilisation analysis of heart failure medicines listed on the PBS

20 December 2024 - At its September 2024 meeting, the PBAC considered a report presenting a utilisation analysis of PBS ...

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Outcome statements for October 2024 stakeholder meetings: oral contraceptives and migraine

9 December 2024 - The Outcome Statements are now available for the Oral Contraceptives Stakeholder Meeting held on 10 October 2024 ...

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HTA Policy and Methods Review update

3 December 2024 - The Minister for Health and Aged Care, the Hon Mark Butler MP has announced the Implementation Advisory ...

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Outcome statement - October 2024 DUSC meeting

15 November 2024 - The outcome statement from the October 2024 DUSC meeting is now available. ...

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HTA review outlines First Nations, pediatric reform and quick, cheap medicine

10 September 2024 - A Government review of Australia’s systems for accessing medicine has said it could slash waiting times ...

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Final reports of the HTA Policy and Methods Review and Enhanced Consumer Engagement Process

10 September 2024 - The reports of the HTA Review and the Enhanced Consumer Engagement Process have been published. ...

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Updates to the HTA Policy and Methods Review

10 July 2024 - The Health Technology Assessment (HTA) Policy and Methods Review concluded on 4 May 2024. The HTA ...

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Four decades of orphan drugs and priorities for the future

6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...

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The rare paediatric disease voucher program creates new treatments. I have new data to prove it.

2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...

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ICER publishes protocol for annual assessment of drug coverage policies that present barriers to fair access

5 June 2024 - This year’s analysis will include the top ten commercial formularies by covered lives, and include drugs ...

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Annual report highlights progress in science, medicines and health in 2023

30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...

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Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval

7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...

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