FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma

1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...

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FDA faces reckoning over short-cut drug approvals

21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...

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The accelerated approval program for cancer drugs — finding the right balance

9 September 2023 - Implementation of the accelerated approval program has been rocky in recent years.  ...

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FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma

14 August 2023 - Today, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer), a bispecific B-cell maturation antigen directed ...

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FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

10 August 2023 - On 9 August 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech) for adults with ...

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Drug companies are minting billions on unproven treatments with FDA shortcut

15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...

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FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

3 April 2023 - Today, the FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) ...

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Clinical trial considerations to support accelerated approval of oncology therapeutics

24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...

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FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

22 March 2023 - Today the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte) for adult patients with metastatic or ...

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Top FDA official: agency needs to start using accelerated approval for gene therapies

20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...

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Travere Therapeutics announces FDA accelerated approval of Filspari (sparsentan), the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy

17 February 2023 - Interim results from the ongoing Phase 3 PROTECT head to head trial demonstrated a rapid, sustained and ...

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FDA gene therapy head raises concern on accelerated approval use

14 February 2023 - More than 1,000 cell and gene therapy clinical trials registered. ...

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Medicare may test policy of paying less for accelerated approval drugs

31 January 2023 - Medicare official hinted Tuesday that Medicare might test a policy of paying less for drugs that ...

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Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway

27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a ...

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FDA may not always require post-approval trials to be enrolled before accelerated approvals

30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...

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