Acadia Pharmaceuticals Inc. announces Phase 2 trial to test efficacy and safety of ACP-204 for Alzheimer's-related psychosis hallucinations and delusions.
Genmab A/S provided updates on FDA and EMA regulatory progress concerning their bispecific T-cell engaging antibody, epcoritamab, which is administered subcutaneously and under review.
Formycon AG, in collaboration with its licensing associate Klinge Biopharma GmbH, has declared the submission of the commercial application for FYB203 to the European Medicines Agency.
Dupixent® considerably cut down on COPD flare-ups in its subsequent effective Phase 3 investigation, hastening its FDA application and affirming its potential as the initial sanctioned biologic treatment for this severe illness.
Innovent makes announcement: China's National Medical Products Administration has permitted and given precedence in reviewing the new drug application, IBI351 - the first KRAS G12C inhibitor from the country.
Acrotech Biopharma and Evive Biotech have successfully received FDA authorization to use Ryzneuta® (Efbemalenograstim alfa injection) for treating Neutropenia caused by Chemotherapy (CIN).
EirGenix Inc. has delivered news regarding the receipt of a marketing endorsement from the European Commission for their trastuzumab biosimilar medication (EG12014).
Vertex Pharmaceuticals has announced that the European Commission has approved an expanded label for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis in children aged 2 to 5 with at least one F508del mutation in the CFTR gene.
Recently, Shanghai MicuRx Pharmaceuticals Co., Ltd. revealed that the first volunteer has been enlisted for the initial Phase I clinical examination of its innovative antibiotic MRX-5 in Australia.