This article was originally published in SRA
New accelerated track for urgent safety-related amendments
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No device-related warning letters were released by the US FDA the week of 26 January.
Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.
The fourth quarter proved to be challenging for Novartis, with its dermatology, ophthalmology and oncology products – and Zolgensma – feeling the impact of COVID-19 lockdowns. The company is hoping for much better things in the second part of 2021.