PTC Therapeutic's Upstaza gene therapy for patients with genetic disorder AADC deficiency has been recommended for approval in the EU, setting up another test of the commercial prospects f
Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – after getting a positive opinion for the drug
Biogen has given up on seeking approval for its Alzheimer's disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it clear the current data for the drug is
A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to people whose lives are blighted by the condition.
The EMA's human medicines committee has said it cannot approve Biogen and Eisai's Alzheimer's disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug.
Biogen and Eisai have said that the EMA's human medicines committee looks unlikely recommended approval of their Alzheimer's drug Aduhelm when it comes up for discussion next month.
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