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October 13, 2023
- PHOENIX Phase 3 trial topline results on track for mid-2024 and will inform regulatory next steps in the EU - Final decision from the European Commission expected by the end of 2023 ...
October 13, 2023
/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human...
October 13, 2023
(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agen...
October 13, 2023
Amylyx Pharmaceuticals Inc. NASDAQ AMLX Amylyx or the Company today announced that the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency EMA confirmed its initial negative opinion on the Marketing Authorisation Application MAA for AMX0035 sodium phenylbutyrate and ursodoxicoltaurine also known as taurursodiol under the trade name ALBRIOZA for the treatment of amyotrophic lateral sclerosis ALS in the European Union EU.
October 13, 2023
Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial If approved, a KEYTRUDA combination would become an option in the EU for the treatment of both...
October 13, 2023
By Adriano Marchese Amylyx Pharmaceuticals said Friday that it received an initial negative opinion from an EU regulator on the marketing authorization...
October 13, 2023
The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and...
October 13, 2023
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass., October 13, 2023--BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab for the treatment of adult patients with relapsed or ref...
October 13, 2023
The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.2,3If...