regulatory approval

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Micrograph showing a small B-cell lymphoma compatible with follicular lymphoma

BeiGene breaks new ground for BTK drugs in blood cancers

BeiGene’s BTK inhibitor Brukinsa has become the first drug in the class to be approved in the US for follicular lymphoma, giving it the broadest label among its rivals.

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FDA clears first OTC glucose biosensor, from Dexcom

Adults in the US who want to measure their blood glucose levels using a wearable sensor will soon be able to buy one over-the-counter (OTC) for the first time.

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FDA says yes to Allecra, no to Venatorx UTI drugs

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but tu

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Interchangeable high-concentration Humira approved in US

For the first time, pharmacists in the US will be able to substitute a cheaper biosimilar version when they receive a prescription for AbbVie’s high-concentration formulat

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Pfizer’s ulcerative colitis drug Velsipity gets EU okay

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s f

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Roche’s Xolair is first medicine for food allergy in US

Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people w

BeiGene breaks new ground for BTK drugs in blood cancers

FDA clears first OTC glucose biosensor, from Dexcom

FDA says yes to Allecra, no to Venatorx UTI drugs

Interchangeable high-concentration Humira approved in US

Pfizer’s ulcerative colitis drug Velsipity gets EU okay

Roche’s Xolair is first medicine for food allergy in US

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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