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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Accelerated approval - an unexpected pathway to value-based pricing?

18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...

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FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours

17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...

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Congress should fix FDA’s accelerated approval program for the next 30 years

12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...

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FDA’s Pazdur challenges attack on accelerated approval program

2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...

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FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway

30 July 2021 - Criticisms of the US FDA’s accelerated approval process have resurfaced after the recent approval of aducanumab ...

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FDA grants accelerated approval for Alzheimer’s drug

7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...

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FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal ...

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FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer

5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...

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Curtailing Medicaid coverage of accelerated approval therapies threatens patients' access

3 May 2021 - To improve their COVID-battered fiscal situations, some states are looking to cut Medicaid, which makes up ...

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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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