This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
The four-week fixed-dose schedule for Imfinzi in NSCLC was also recently approved by the US Food and Drug Administration (FDA). ... The FDA also approved the additional dosing option for patients with previously treated advanced bladder cancer.
FDA priority review is based on data from the phase 3 FIDELIO-DKD trial. ... The FDA submission is based on data from the phase 3 FIDELIO-DKD trial, which evaluated finerenone in patients with CKD and T2D.
Following the fast-track designation, the FDA will plan to reach a decision on Merck's vaccine by 18 July. ... Pfizer’s 20-valent candidate was given a priority review by the FDA in December 2020, with the goal of announcing a decision in June this year
Another amyloid-targeting treatment, Biogen’s aducanumab, is currently being reviewed by the US Food and Drug Administration (FDA). ... Although the FDA is not required to follow guidance from expert panel decisions, it usually does so.
Novartis’ gene therapy was approved to treat SMA in patients aged two years and younger by the FDA in May 2019, with a price-tag of $2.1m per patient – making
The US Food and Drug Administration (FDA) has also given the Moderna vaccine an emergency use authorisation for the prevention of COVID-19 in individuals aged 18 years and older. ... It is the second COVID-19 vaccine to receive an EUA from the FDA
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What were the trial results that led to this EUA? An EUA is a mechanism through which the Food and Drug Administration (FDA) can approve the temporary use of an investigational ... The FDA has approved remdesivir under the brand name Veklury for the
As a result, recently published FDA guidance provides recommendations for improving clinical trial diversity, including decentralised strategies such as reducing site visit frequency, when appropriate, in addition to encouraging the use ... In fact,
Furthermore, a priority review designation by the FDA or EMA signals to the market an expectation that the drug will provide an improvement over currently available treatment.
Biosimilars – FDA-approved treatments that match their reference medicine in terms of quality, safety and efficacy – have an important role in creating sustainability for overburdened health systems through increased competition. ... Myeloid growth
FDA approval – in this case for a project that can treat inherited vision loss. ... body to target motor neurone disease, is FDA approved and developed by Avexis, but it won’t see widespread availability due to a price tag of $2.1m per treatment.
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regional health communications campaigns. In her new role, she will leverage her expertise in FDA/EMA communications, patient and physician education, scientific communications, issues management and celebrity engagement to serve JPA
The combination of his strong experience in regulatory affairs, not only with the FDA but on a broad international basis with a proven track record and experience from orphan drug development
US-based biopharmaceutical services company Parexel has bolstered its regulatory services team with the addition of three senior executives from the FDA and pharma. ... He has previously worked for the likes of Novartis, Igenix and the FDA.
Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings
Dr Jenkins is also a committee member of the science board to the US Food and Drug Administration (FDA) and serves on the advisory board of its Center for Talent Innovation
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In addition to this there has been a huge increase in the number of orphan treatments granted access by the US Food and Drug Administration (FDA) (862 vs 46) but this
In November 2020, PhRMA announced the first-ever, industry-wide principles on clinical trial diversity. The principles were approved by the PhRMA Boards of Directors and will take effect in April 2021. PhRMA have taken the existing principles a step
The FDA provides key examples of how to improve study design and conduct to enhance enrolment:. ... To help minimise underrepresentation in these studies, the FDA outlined some changes in the enrolment process:.
In the US, for example, the FDA is placing increasing pressure on pharma companies to run trials with patients who better resemble the overall population; a scramble is on to make ... The FDA guidance on patient diversity does not specifically dictate
Regulatory and reimbursement agencies are also starting to allow, if not encourage the patient perspective, with the FDA stating in guidance in 2018 that ‘patient engagement is critical throughout the medical ... Whilst I would agree with the FDA that
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