15/04/2026 Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP ( Ref ) Savara announced that the FDA had extended the review period for the malgramostim ( Molgramostim Inhalation Solution ) BLA in autoimmune pulmonary alveolar proteinosis (Autoimmune PAP) by three months The Agency was reviewing the molgramostim BLA under Pr

26/03/2026 UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG Soligenix received orphan drug designation from the European Commission for SGX945 for the treatment of Behçet's Disease UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG ( Ref ) UCB announced that the European Medicines Agency’s CHMP had issued a positive opinion to expand the use of ZILBRYSQ® (zilucoplan; C5 inhibitor), with a new pre-filled pen device as an add

03/03/2026 UCB and Antengene entered into a global license agreement for ATG-201 targeting B cell-related autoimmune diseases Johnson & Johnson received US FDA fast track designation for nipocalimab in SLE Priovant’s brepocitinib received US FDA acceptance and priority review for patients with dermatomyositis COUR Pharma announced Phase 2a results of CNP-104 in PBC Kyowa Kirin announced the discontinuation of rocatinlimab clinical trials UCB and Antengene entered into a globa