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AZ, Amgen get speedy FDA review for asthma drug tezepelumab

The FDA has started a priority review of AstraZeneca and Amgen's severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022.

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FDA rejects Provention's type 1 diabetes drug teplizumab

The FDA indicated something was not well with Provention Bio's filing for type 1 diabetes therapy teplizumab in April when it delayed its review.

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Novartis tries to rescue stalled inclisiran filing with FDA

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes

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Merck pulls Keytruda's FDA nod for third-line stomach cancer

Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this sett

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FDA gives Roche's Actemra emergency okay for severe COVID

Roche has been granted emergency approval by the FDA for its arthritis drug Actemra as a treatment for patients aged two or over who are hospitalised with severe COVOD-19 symptoms.

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Roche eyes October decision by FDA for wet AMD implant

The FDA has started a review of a new implant version of Roche's ranibizumab therapy for wet age-related macular degeneration, that could offer patients with the sight-robbing disorder an a

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

FDA rejects Provention's type 1 diabetes drug teplizumab

Novartis tries to rescue stalled inclisiran filing with FDA

Merck pulls Keytruda's FDA nod for third-line stomach cancer

FDA gives Roche's Actemra emergency okay for severe COVID

Roche eyes October decision by FDA for wet AMD implant

GBL joins CVC in €10.7bn takeover bid for Recordati

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