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accelerated approval
This page shows the latest accelerated approval news and features for those working in and with pharma, biotech and healthcare.
Seagen and Genmab’s Tivdak shows promise in phase 3 cervical cancer trial
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
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Merck receives EC approval for Keytruda combination in gastric cancer
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
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Eli Lilly shares positive late-stage results for Retevmo in thyroid cancer
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
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Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer
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
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Roche’s Genentech and Blueprint receive full FDA approval for Gavreto in lung cancer
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
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Merck granted positive CHMP opinion for Keytruda combination in gastric cancer
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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Mapping the patient journey: eight ways to improve support programmes
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
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How will COVID-19 affect uptake of vaccinations against other diseases?
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.
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Surviving cancer: a new era for patients
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
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The Cystic Fibrosis Buyers’ Club
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
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AstraZeneca: building a new ‘open innovation’ pharma company
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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What does the future hold for Light-chain Amyloidosis?
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.
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Future focus: 3 tools for launching fast in the face of uncertainty
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
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The future of dementia and the important role of healthcare communication in raising awareness
This allows for an accelerated approval for treatments based on biomarkers that are reasonably likely to predict clinical benefit.
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Infographic: China: How to keep up and win in the world's fastest changing healthcare market
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.
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Parachuting Behind Enemy Lines: OncoSec’s Attack on Visceral Tumors via Its New Visceral Lesion Applicator (VLA)
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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- AstraZeneca and Daiichi Sankyo share positive results from phase 3 breast cancer study
- ICR and Merck renew strategic alliance for development of new cancer drugs
- DeepMind’s AI tool classifies effects of mutations in genetic diseases
- CDC awards over $23m to Johns Hopkins Center for Health Security project
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Wiley is a global leader in research and education. We clear the path for seekers of knowledge, leading the way...
Latest intelligence
- The importance of accelerating clinical trial diversity
- Diversity shouldn’t be an afterthought – it’s an investment in the credibility of scientific endeavour...
- Digital Opinion Leaders: The Role of Influencers in Medical Communications
- There are many informed, knowledgeable HCPs who talk about a disease state online, but not all of them are influencers. This paper explores who digital opinion leaders are and how...
- Creating Hope Though Action – World Suicide Prevention Day
- At Mednet Group, we believe that actions speak louder than words. That's why we're getting behind this year's Suicide Prevention Day campaign of 'creating hope through action'....
