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FDA

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

Pfizer’s Prevnar-13 successor takes aim at Merck rival

Pfizer’s Prevnar-13 successor takes aim at Merck rival

The FDA also granted fast-track status for PF-06482077 last year. Pfizer says it is expecting to start phase 3 trials of the new vaccine in the coming months, and ... We look forward to continuing our dialogue with the FDA so that we can accelerate the

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  • Cancer immunotherapy: What's on the horizon? Cancer immunotherapy: What's on the horizon?

    Between November 2016 and October 2017, the FDA approved 31 new therapies for more than 16 types of tumour, including the first cell-based therapies, the first tumour-agnostic drugs and ... also extending to targeted cancer drugs, with Loxo Oncology and

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... However the FDA placed a clinical hold on the IND for the candidate in May,

  • 30 women leaders in UK healthcare (part 3) 30 women leaders in UK healthcare (part 3)

    2004. Fifteen years on, the company’s lead product candidate, Lynovex, for the treatment of acute pulmonary exacerbations in Cystic Fibrosis, was recently granted FDA Fast Track Designation.

  • 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.

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