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New appointments in the Legal Department and the Regulatory Science and Innovation Task Force
10 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
Eurneffy (epinephrine) is an alternative to injectable formulations
Winrevair received support through PRIority Medicines (PRIME) scheme due to its potential to bring a major therapeutic advantage over existing therapies
Benefits of Ocaliva no longer considered to outweigh its risks
MSSG recommendations for all stakeholders and upcoming multistakeholder workshop
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting.
Revised rules for Clinical Trials Information System (CTIS) become applicable
Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it.
Start of review of painkiller metamizole and risk of secondary cancers with CAR T-cell medicines.