Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions

4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...

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FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies

18 April 2022 - Five years ago, the FDA launched a new program with the best of intentions: to speed ...

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Alzheimer's drug makers seek accelerated FDA review despite U.S. coverage decision

8 April 2022 - Eisai and Eli Lilly on Friday said they still plan to seek accelerated U.S. approval for ...

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‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval

9 April 2022 - Whither accelerated approval? ...

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Panel scrutinises quick FDA drug approvals

17 March 2022 - A House committee will spotlight an FDA process that’s been criticised as putting some of the ...

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Legislation would set expiration for FDA’s accelerated approvals

9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...

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Key Democrat moves to crack down on FDA accelerated approvals

7 March 2022 - A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and ...

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CTI BioPharma announces FDA accelerated approval of Vonjo (pacritinib) for the treatment of adult patients with myelofibrosis and thrombocytopenia

28 February 2022 - New drug application approved under priority review. ...

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Biogen Alzheimer drug row augers flux in fast FDA approvals

14 February 2022 - Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation ...

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Global consequences of the US FDA's accelerated approval of cancer drugs

1 February 2022 - The accelerated approval system is a fast track drug approval pathway created by the US FDA in ...

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FDA grants Calliditas Therapeutics accelerated approval of Tarpeyo (budesonide) to reduce proteinuria in IgA nephropathy

15 December 2021 - Tarpeyo (developed under the project name Nefecon) is the first and only FDA approved treatment that was ...

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Recent trends in Medicaid spending and use of drugs with US Food and Drug Administration accelerated approval

8 October 2021 - In this cross-sectional study of 216 drugs granted accelerated approval from 1992 through 2020, relative to all ...

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FDA’s accelerated approval program: is change on the way?

11 October 2021 - The U.S. FDA launched its accelerated approval program in 1992, offering a pathway to bring life saving ...

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A middle ground for accelerated drug approval—lessons from aducanumab

23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...

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Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...

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