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Harmony's sleep disorder drug Wakix gets US label extension

Harmony Biosciences has scored an expanded use for its Wakix narcolepsy drug to include cataplexy – a symptom of the sleep disorder that can cause total body collapse.

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FDA gives COVID-19 vaccine ‘advice’ after White House blocks...

The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach pub

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CTI wins over FDA to claim early review of myelofibrosis dru...

Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused b

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EMA review of AZ’s COVID-19 vaccine imminent; report

The EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the FDA is widening its investigation into the shot’s safety, according to reports

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FDA slams brakes on Inovio's final-stage COVID-19 vaccine tr...

Inovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for more information, sending its shares into a swift decline.

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