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FDA delays decision on Roche's SMA drug to review extra data

The FDA has extended its review of Roche’s spinal muscular atrophy (SMA) drug risdiplam after the pharma submitted additional data.

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FDA lets off Novartis after gene therapy data row

Novartis is off the hook following the FDA’s review of data manipulation in the filing of its hugely expensive spinal muscular atrophy gene therapy Zolgensma.

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FDA grants emergency use of malaria drugs against COVID-19

The FDA has approved emergency use of malaria drugs championed by president Donald Trump for use in patients hospitalised with COVID-19, after warning against the potentially lethal consequ

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FDA approves fast tests for coronavirus as US faces shortage...

The FDA has approved two fast tests for the coronavirus that is causing the COVID-19 epidemic, which are able to produce results within hours instead of days.

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FDA backs Glenmark's rival to AZ's blockbuster Farxiga

AstraZeneca’s diabetes drug Farxiga could face generic competition in the US, after the FDA gave tentative approval to a generic rival from India’s Glenmark, although it is unclear when the

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Janssen files MS pill, ahead of FDA decision on BMS' rival

Janssen has filed its ponesimod pill with the FDA for treatment of adults with relapsing multiple sclerosis, days before the regulator is due to make a decision on a rival from Bristol-Myer

FDA delays decision on Roche's SMA drug to review extra data

FDA lets off Novartis after gene therapy data row

FDA grants emergency use of malaria drugs against COVID-19

FDA approves fast tests for coronavirus as US faces shortage...

FDA backs Glenmark's rival to AZ's blockbuster Farxiga

Janssen files MS pill, ahead of FDA decision on BMS' rival

Treating the chronic diseases GLP-1s miss, with Laurent Auda...

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