'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says

26 February 2019 - "The sick people are helping to subsidise the healthy people. That's not how insurance is supposed to ...

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Product withdrawn after overseas reports of inflammatory brain disorders

15 March 2018 - Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw ...

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EMA to relocate to Amsterdam, the Netherlands

20 November 2017 - Agency to begin working immediately with Dutch government to ensure successful move by end of March ...

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MHRA chief floats faster reviews, closer ties to NICE

19 October 2017 - The head of the United Kingdom’s regulatory agency has sketched out some of the ways it ...

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FDA speeding generic drug approvals: not just lip service

10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...

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Agenda for July 2016 CHMP meeting

19 July 2016 - The agenda for the 18-21 July 2016 CHMP meeting is now available. ...

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EMA publishes monthly statistics

23 June 2016 - The EMA has published a monthly statistics report on the medicinal products for human use that ...

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Registration of new chemical entities in Australia in 2015

5 January 2016 - Each year, approximately 40 new prescription medicines containing new active substances are registered. ...

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FDA approves two new drug treatments for diabetes mellitus

25 September 2015 - The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin ...

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Will the FDA approve all 3 of these cancer drugs in October?

25 September 2015 - The World Health Organization identified more than 14,000 disease, disorders, and ailments in 2011, but none continues ...

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EU marketing approval granted for VivaGel BV

24 September 2015 - Starpharma today announced it has received, overnight, marketing approval in the European Union (EU) for VivaGel BV ...

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TGA publishes another 6 AusPARs

25 September 2015 - The TGA has published another six AusPARs.  ...

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Keryx receives European approval for Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphataemia in adults with chronic kidney disease

24 September 2015 - Keryx Biopharmaceuticals, Inc. today announced that the European Commission has approved Fexeric (ferric citrate coordination complex) for ...

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AcelRx Pharmaceuticals reports that the European Commission has granted marketing authorization for Zalviso for treatment of acute moderate-to-severe post-operative pain in adult patients

22 September 2015 - AcelRx Pharmaceuticals, Inc. announced today that the European Commission (EC) has approved Zalviso (15 micrograms sufentanil sublingual ...

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FDA approves new oral medication to treat patients with advanced colorectal cancer

22 September 2015 - The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and ...

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