TGA publishes AusPAR for Entresto

14 October 2016 - The TGA has published an AusPAR for Novartis' Entresto. ...

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FY 2016 generic approvals by FDA: a new record under GDUFA

12 October 2016 - The US FDA published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this ...

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EMA publishes EPAR for Cabometyx (cabozantinib maleate)

12 October 2016 - The EMA has published an EPAR for Ipsen's Cabometyx. ...

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ICER releases corrected evidence report on treatments for non-small-cell lung cancer

7 October 2016 - PD-1 value-based price benchmarks are updated while the main conclusions of the analysis remain unchanged. ...

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Human medicines highlights - September 2016

7 October 2016 - Key information for patients, consumers and healthcare professionals published monthly by the EMA. ...

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EMA publishes EPAR for Truberzi

29 September - The EMA has published an EPAR for Allergan's Truberzi (eluxadoline). ...

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ICER releases evidence report on treatments for non-small cell lung cancer

29 September 2016 - The Institute for Clinical and Economic Review has released an evidence report assessing the comparative clinical effectiveness ...

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EMA publishes EPAR for Nordimet

29 September 2016 - The EMA has published an EPAR for Nordic Pharma's Nordimet. ...

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TGA performance statistics report: July 2015 to June 2016

28 September 2016 - The TGA, through the Performance Statistics Report, provides detailed statistical information on its performance to stakeholders. ...

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TGA publishes AusPAR for Orkambi

21 September 2016 - The TGA has published an AusPAR for Vertex's combination product for cystic fibrosis. ...

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TGA publishes AusPAR for Lenvima (lenvatinib mesylate)

9 September 2016 - The TGA has published an AusPAR for Eisai's vascular endothelial growth factor inhibitor inhibitor. ...

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TGA publishes AusPAR for Opdivo (nivolumab)

7 September 2016 - The TGA has published an AusPAR for BMS' Opdivo. ...

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TGA publishes AusPAR for nalfemene hydrochloride dihydrate (Selincro)

2 September 2016 - The TGA has published an AusPAR for Lundbeck's Selincro. ...

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TGA publishes AusPAR for pirfenidone (Esbriet)

29 August 2016 - The TGA hs published an AusPAR for Roche's Esbriet. ...

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Summary of the outcomes from the PBAC July 2016 meeting

19 August 2016 - The outcomes from the PBAC July 2016 meeting are now in the public domain. ...

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