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

10/03/2026 Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD ( Ref ) Redx Pharma announced that the US FDA had granted fast track designation to RXC008 (a GI-restricted pan-ROCK inhibitor) for the treatment of patients with fibrostenotic crohn’s disease (CD) Lisa Anson, CEO, Redx Pharma: “ Redx have been working closely with the FDA and the STAR consortium to define the regulatory