AVEO Oncology announced that the FDA accepted for filing its New Drug Application (NDA) seeking approval for Fotivda (tivozanib), the Company’s next-generation vascular endothelial growth factor receptor tyrosine… read more.
BioMarin Pharmaceutical Inc. announced an update to its previously reported results of an open-label Phase 1/II study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with… read more.
BeiGene announced follow-up data from the Phase III ASPEN trial comparing BRUKINSA (zanubrutinib) to ibrutinib for the treatment of Waldenström’s macroglobulinemia. Data presented from the Phase III ASPEN… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zercepac (trastuzumab), from Accord… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Hepcludex (bulevirtide), from MYR GmbH, intended… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xenleta (lefamulin), from Nabriva… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lynparza… read more.
Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic… read more.
The EMA’s CHMP has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine Zabdeno (formerly Ad26.ZEBOV) + Mvabea (formerly MVA-BN-Filo), from Janssen-Cilag International,… read more.
Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced that the Phase III trial of roluperidone to… read more.
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