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FDA`

This page shows the latest FDA` news and features for those working in and with pharma, biotech and healthcare.

Rigel and Ultragenyx claim approvals for rare drugs

Rigel and Ultragenyx claim approvals for rare drugs

The FDA gave the go-ahead to a pair of rare disease therapies this week, both marking the first-ever approvals for developers Rigel Pharmaceuticals and Ultragenyx. ... According to the company, Tavalisse targets the underlying autoimmune cause of the

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  • BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer

    The combination of Opdivo and Yervoy lies at the heart of much of Bristol-Myers Squibb’s ambition in immuno-oncology, and an FDA approval for the pairing in kidney cancer ... BMS notes that Opdivo and Yervoy was given a priority review by the FDA last

  • Alkermes slumps as FDA turns down depression drug Alkermes slumps as FDA turns down depression drug

    Alkermes was hoping that the massive unmet need in patients with MDD would help sway the FDA. ... Alkermes strongly disagrees with the FDA's conclusions and plans to appeal the FDA's decision, ”said the company in a statement.

  • Seattle Genetics claims key US approval for Adcetris Seattle Genetics claims key US approval for Adcetris

    The FDA has cleared it for stage III and stage IV Hodgkin’s lymphoma only, which account for around half of all new diagnoses. ... According to the FDA, there were around 8, 260 people diagnosed with Hodgkin’s lymphoma last year.

  • FDA approves another home genetic testing service FDA approves another home genetic testing service

    FDA approves another home genetic testing service. 23andMe’s kit will check for an increased risk of certain cancers developing. ... The approval is welcomed news for the online genetics firm, particularly because of the FDA’s initial rejection of

  • AbbVie’s uterine fibroids drug aces second phase III trial AbbVie’s uterine fibroids drug aces second phase III trial

    AbbVie’ s uterine fibroids drug aces second phase III trial. An FDA verdict is expected in the US in the coming weeks. ... The two companies are currently waiting for an FDA verdict in the US in the coming weeks on elagolix as a treatment for

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Latest Intelligence

  • Significant figures Significant figures

    US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status. ... Offering an on-label treatment. The current standard of care for treating patients with NTM lung disease consists of a triple

  • The good, the bad and the ugly The good, the bad and the ugly

    The main drivers of revenue for Roche are well-established, standard-of-care blockbuster oncology drugs including Rituxan, Herceptin and Avastin. ... The data this article was based on is available in full online: pmlive.com/top_pharma_list.

  • The gold standard of scientific evidence The gold standard of scientific evidence

    The gold standard of scientific evidence. Will randomised controlled trials become a thing of the past? ... The FDA uses RWE to monitor drug safety as part of the Sentinel project.

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    During 2016 the FDA issued 14 CRLs, compared to just two in 2015. ... We expect the strong overall trend for more orphan drugs submitted to and approved by the FDA and the EMA to continue.

  • Charting a course for expansion Charting a course for expansion

    Behind that as a focus product is Dysport, a botulinum toxin that was approved in the US by the FDA in August for a new indication to treat paediatric lower limb ... It's because of the data - the overall objective response rates, the progression-free

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