WebMar 11, 2024 · The FDA is reviewing Akebia Therapeutics’ Vafseo for treatment of anemia due to chronic kidney disease (CKD) in both adults on dialysis and adults not on dialysis. … WebMay 31, 2024 · The fate of Amylyx’s only project AMX0035, intended to treat amyotrophic lateral sclerosis, will be decided by June 29. The drug’s earlier FDA panel meeting was negative, but only just, with a vote of 6-4 that efficacy had not been established. The project was filed on a single phase 2 study called Centaur; however, there were questions ...
Evive Biotech meets primary and secondary endpoints in global
WebJul 4, 2024 · FDA adcoms also recommended that Covid vaccines from Moderna and Pfizer/Biontech move into younger populations, with expanded EUAs quickly following. ... Evive Biotech (private) Chemotherapy-induced neutropenia-No decision yet: SH-111: Shorla Oncology (private) Undisclosed project for T-cell leukaemia- WebMar 31, 2024 · BLA submission to the U.S. FDA follows successful conclusion of Evive’s Global Phase III Clinical Trial for chemotherapy-induced neutropenia in breast cancer … gachgiare24h
Ryzneuta (efbemalenograstim alpha) / Yifan Pharma - LARVOL
WebApr 2, 2015 · EVIVE Biotechnology: ClinicalTrials.gov Identifier: NCT02406651 Other Study ID Numbers: GC-652-02 : First Posted: April 2, 2015 Key Record Dates: Results … WebMarch 31, 2024. Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta (Yifan Pharma Press Release) - "Evive Biotech...today announced the submission of its Biologics License Application (BLA) for Ryzneuta™ (also known as F-627) to the US Food & Drug Administration (FDA). The submission follows the successful … WebAbout us. Evive Biotech is a global biopharmaceutical company devoted to developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary … gachette traduction