Drug makers push back on data requirements in Australia’s provisional approval pathway

5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for ...

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Provisional approval pathway for prescription medicines

1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...

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Flimsy evidence behind many FDA approvals

16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...

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Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration

15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications.  ...

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Bristol-Myers Squibb receives accelerated approval of Opdivo (nivolumab) from the U.S. Food and Drug Administration

22 December 2014 - First approval of Opdivo in the United States. ...

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Major flaws in US drugs with 'accelerated' approval, research suggests

7 June 2017 - A new study published today has exposed major flaws in the fast tracking of some drugs ...

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FDA approves Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy

5 August 2016 - Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death ...

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Accelerated approval and expensive drugs — a challenging combination

24 May 2017 - For serious or life-threatening disease, the FDA can approve drugs on the basis of surrogate end points ...

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Accelerating development of scientific evidence for medical products within the existing US regulatory framework

1 May 2017 - Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about ...

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Takeda announces FDA accelerated approval of Alunbrig (brigatinib)

29 April 2017 - Alunbrig approved for ALK+ metastatic non-small-cell lung cancer patients who have progressed on or are intolerant ...

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FDA grants Roche’s Tecentriq (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer

18 April 2017 - First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable ...

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EU rapid drug approval plan worries some national HTA agencies

29 March 2017 - A push by the EMA to speed up the approval of new drugs that show promise ...

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A better balance between accelerated access and high priced new drugs: a new conditional approval option

20 March 2017 - There are two different storms brewing in the pharmaceutical world. On the one hand there is ...

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FDA grants accelerated approval to new treatment for advanced ovarian cancer

19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain ...

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Improving the accelerated pathway to cancer drug approvals

29 November 2016 - The US FDA must balance the need to bring potentially lifesaving drugs to market with the need ...

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