FDA - International Pharmaceutical Industry

Volume 16 Issue 1

Electronics and Data, How Effective are Personal Electronics in Helping Patients to Maintain Good Health?

What does the Future Hold for Patients? In Oct 2017 the Adherium stock was trading around AUS $22 with the Rapihaler device FDA approved. Today 2024 – 16 differen...

15 April 2024 Volume 16 Issue 1 | Editorial Archive approved | compliance

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Volume 14 issue 3

The Transformational Potential of Prioritising Data Today

Covid has spurred regulators towards a more agile and innovation-supporting future, paving the way for new opportunities for all. If life sciences companies embrace ...

10 October 2022 Volume 14 issue 3 Affairs | agile

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Volume 13 Issue 4

Preparing for FDA Remote Inspections: What to Expect for 2022

If there’s one thing 2020 taught the world, it’s that the road ahead is ever-changing. Given the Delta variant on the rise and the significant backlog of FDA inspect...

24 November 2021 Volume 13 Issue 4 FDA | FDA Remote Inspections

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Volume 13 Issue 4

It’s Now Time for Your OPDP Submissions to be FDA Compliant | Are You Ready?

The Prescribing Information, Labeling, and any other materials used for the promotion of Drug Products for their approved indication, or intended purpose of use, are...

24 November 2021 Volume 13 Issue 4 FDA | FDA Compliant

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News

FDA approves Exelixis’ Cabometyx for differentiated thyroid cancer

The US Food and Drug Administration (FDA) has approved Exelixis’ Cabometyx (cabozantinib) for the treatment of patients with previously treated radioactive iodine-re...

22 September 2021 News Cabometyx | cabozantinib

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News

FDA approves first COVID-19 vaccine

The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be market...

25 August 2021 News COVID-19 | emergency use authorization

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News

FDA approval for Xywav for idiopathic hypersomnia in adults

Jazz Pharmaceutical’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults has been granted...

13 August 2021 News FDA | Food and Drug Administration

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News

FDA approves Keytruda plus Lenvima for advanced kidney cancer

The US Food and Drug Administration (FDA) has approved a combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for the fi...

13 August 2021 News FDA | Food and Drug Administration

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News

US rejects AZ and FibroGen’s anaemia drug roxadustat

The US Food and Drug Administration (US) has handed AstraZeneca a complete response letter (CRL) regarding its anaemia drug roxadustat. AZ had submitted a new dru...

13 August 2021 News anaemia drug | AstraZeneca

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News

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

The U.S. Food and Drug Administration today approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. T...

31 July 2018 News approves | device

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