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There have been several changes to the pharmaceutical and biotech regulatory landscape in 2023. The short and long-term impacts of these changes are relatively unknown; however, all could shape the regulatory landscape for life sciences in 2024 and beyond.What are the regulatory changes?Reform of the European Union&...
NDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term...
Takeda TSE4502NYSETAK today announced that the European Medicines Agencys EMA Committee for Medicinal Products for Human Use CHMP has recommended the approval under exceptional circumstances of recombinant ADAMTS13 rADAMTS13 for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.
On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional...
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for...