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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. ... Rigel got a green light from the FDA for chronic immune thrombocytopenia (ITP) therapy

Latest news

  • 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

    According to the FDA, there were around 8, 260 people diagnosed with Hodgkin’s lymphoma last year. ... Last November it was granted FDA approval in adult patients with cutaneous T cell lymphoma (CTCL) and there is more to come.

  • 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 US Food and Drug Administration (FDA) has authorised another one of 23andMe’s home genetic kits, and this one

  • 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

  • A new era of smart pharma A new era of smart pharma

    The FDA recently approved a ‘digital pill’. The pill includes an embedded sensor that digitally tracks if patients have ingested it.

  • Significant figures Significant figures

    US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status.

  • Deal Watch January 2018

    In October 2017 GSK's QS-21 Stimulon herpes zoster vaccine, Shingrix, was approved by the FDA.

  • Drug safety

    Healthcare terms - Drug safety.

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

    The Israeli multinational has blamed the decline on the increase in generic drug approvals by the FDA, saying that increased competition and ‘customer consolidation’had hurt sales.

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