This page shows the latest accelerated approval news and features for those working in and with pharma, biotech and healthcare.
The drug received FDA accelerated approval in 2021 to treat patients with advanced disease. ... The positive readout adds to the previous results from innovaTV 204, which served as the basis for the US Food and Drug Administration’s (FDA) accelerated
With [the] approval of Keytruda, we’re proud that patients whose tumours express PD-L1 with a combined positive score of one or more and healthcare providers in the EU will ... The Keytruda regimen has already been granted accelerated approval in the
Retevmo gained its first MTC authorisation in 2020 under the US Food and Drug Administration’s accelerated approval pathway, under which the regulator may approve drugs for serious conditions where there
Janssen, a Johnson &Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed ... In line with the FDA’s accelerated approval
The targeted therapy was granted accelerated approval for the NSCLC indication in 2020. ... The drug was authorised for the NSCLC indication in 2020 through the FDA's accelerated approval pathway, under which the regulator may approve drugs for serious
The Keytruda regimen has already been granted accelerated approval in the US for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.
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In some areas, such as gene therapies and high-cost cancer treatments, accelerated approval and early access schemes are conditional on capturing real-world outcomes data – and patient support tools provide
A particular threat in this regard could come from the accelerated clinical development programmes and expedited approval processes that are being put in place to push through SARS-CoV-2 vaccines.
The FDA recently granted accelerated approval for the ADC trastuzumab-deruxtecan in patients with breast cancer, with progression-free survival (PFS) rates showing that longer life is a real possibility – a
The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made
Two of these five new launches received accelerated approval, confirming their innovative status, plus the firm also clocked up 14 other regulatory approvals across indication expan- sion and LCM projects in
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approval in combination with CyBorD for the treatment of newly diagnosed adult patients with AL amyloidosis. ... These treatments are often approved based on single arm clinical trials via an accelerated process.
Numerous factors can slow down a product launch, and these barriers only become more challenging in an accelerated and rapid timeline. ... However, they are also aware that the regulatory body may not grant them accelerated or fast-track approval, and
This allows for an accelerated approval for treatments based on biomarkers that are reasonably likely to predict clinical benefit.
Our latest infographic outlines the changes to the clinical trial process, accelerated drug approval, fast track of rare disease products and access opportunities in China's evolving healthcare environment.
Poster 717/Abstract 11375. 15. US Food and Drug Administration. Drugs. FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib. ... Accessed March 5, 2019. US Food and Drug Administration. Drugs. FDA grants accelerated
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