FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis

15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination ...

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FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...

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Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...

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U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) for patients with hepatocellular carcinoma previously treated with sorafenib

11 March 2020 - Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting. ...

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FDA approves voxelotor for sickle cell disease

25 November 2019 - The Food and Drug Administration has granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for ...

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FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage

14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...

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Fast-track drug approval, designed for emergencies, is now routine

5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...

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FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials

5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...

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Assessment of the clinical benefit of cancer drugs receiving accelerated approval

28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have ...

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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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