US FDA conducted extensive re-analyses of Celgene's AML therapy Idhifa, resulting in full approval based on complete remission findings instead of the accelerated approval based on overall response rate sought by the NDA.
In an unusual turn of events, The US FDA's disagreement with the primary endpoint used in the pivotal (and only) clinical study supporting Celgene Corp.'s NDA for the acute myeloid leukemia (AML) therapy Idhifa resulted in a better approval outcome than the company had anticipated.
Review documents for Idhifa (enasidenib) describe how an NDA seeking accelerated approval based on overall response rate (ORR) became a...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
