GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation

22 November 2022 - GSK today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep ...

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FDA cancer chief wants quicker ways to pull failed drugs

17 November 2022 - Makena highlights need to make system more nimble. ...

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FDA grants accelerated approval to mirvetuximab soravtansine-gynx for folate receptor alfa positive, platinum resistant epithelial ovarian, fallopian tube, or peritoneal cancer

14 November 2022 - Today the FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with folate ...

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FDA panel vote highlights accelerated approval concerns

25 October 2022 -  Last week’s overwhelming vote in favour of pulling preterm-birth drug Makena from the market — and ...

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What the Makena vote means about accelerated approval, trust, and the FDA

19 October 2022 - On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that ...

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FDA grants accelerated approval to futibatinib for cholangiocarcinoma

30 September 2022 - Today, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho) for adult patients ...

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The on- and off-ramps of oncology accelerated approval

21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...

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bluebird bio receives FDA accelerated approval for Skysona gene therapy for early, active cerebral adrenoleukodystrophy

16 September 2022 - Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys ...

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Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials

17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...

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Accelerated approval - taking the FDA’s concerns seriously

6 July 2022 - User-fee re-authorisation creates new opportunities for the FDA to address issues with its accelerated-approval program, including the ...

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Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process

23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...

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Accelerated approval: unfulfilled promises for FDA’s expedited review program

27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...

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Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals

27 May 2022 -  The Senate is taking pains to avoid another Aduhelm controversy. ...

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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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