regulatory

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GSK gets June 2023 FDA decision date for momelotinib

The clock is now ticking on the FDA's review of GSK's momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 billion

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Roche eyes April FDA verdict on Polivy as first-line lymphom...

The FDA has started a review of Roche's Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move the drug further up the treatment p

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Biogen gets much-needed pipeline lift with speedy ALS drug r...

Beleaguered Biogen has been handed some encouraging news from the FDA, after the regulator agreed to complete its review of amyotrophic lateral sclerosis (ALS) therapy tofersen within six m

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Pfizer, Flynn fined £70m in resurrected epilepsy drug pricin...

Drugmakers Pfizer and Flynn Pharma have been fined £70 million ($84 million) by the UK Competition and Markets Authority (CMA) for overcharging the NHS for a widely-used epilepsy drug.

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Young attractive female scientist holding a red transparent pill with futuristic scientific air interface with chemical formulas and research data in the foreground

EMA pilot will see if clinical trial data should be digested...

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the 'raw data' from clinical trials submitted in support of new marketing application along

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