Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication

29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...

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FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer

28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of ...

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FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer

27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of ...

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“Dangling” accelerated approvals in oncology

21 April 2021 - The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing ...

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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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