18/09/2026 CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS Novartis’ Cosentyx® received a positive CHMP opinion for PMR Klygefa recommended for EU approval for gMG Alfasigma’s filgotinib received a positive CHMP opinion for axSpA CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS (Ref) The EMA’s CHMP recommended approval of Ocrevus® (ocrelizumab; CD20 inhibitor) intravenous infusion for patients aged ≥10

16/09/2026 Sling therapeutics dosed the first patient in the Phase 3 trial of linsitinib for TED. Sling therapeutics dosed the first patient in the Phase 3 trial of linsitinib for TED. (Ref) First patient was dosed in Sling Therapeutics’ Phase 3, ORBIT/ NCT07753603 trial evaluating linsitinib (an insulin-like growth factor-1 receptor inhibitor) in adult with moderate to severe active thyroid eye disease (TED). The trial is expected to enroll ~ 130 participants, with the propo

14/09/2026 AbelZeta’s C-CAR168 received FDA IND clearance for PMS Takeda’s zasocitinib won US FDA priority review in PsO. AbelZeta’s C-CAR168 received FDA IND clearance for PMS. (Ref) The US FDA cleared AbelZeta Pharma’s Investigational New Drug (IND) application for a Phase 1b/2 trial of C-CAR168 (an anti-CD20/BCMA bispecific CAR-T), in patients with progressive multiple sclerosis (PMS) refractory to standard therapy. The clearance expanded C-CAR168’s development into refrac

10/09/2026 US FDA granted Priority Review to Roche’s Enspryng for MOGAD US FDA granted Priority Review to Roche’s Enspryng for MOGAD. (Ref) Roche announced that the US FDA had granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab; anti- IL-6) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The filing acceptance was based on positive results from the Phase 3, METEOROID study, whi

09/09/2026 UCB received US FDA BTD for CIMZIA in pregnant women with antiphospholipid syndrome. Beeline Medicines announced topline results from the Phase 2 study of afimetoran in SLE. UCB received US FDA BTD for CIMZIA in pregnant women with antiphospholipid syndrome. (Ref) UCB announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to CIMZIA® (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in addition to standard

08/09/2026 Vor Bio announced the completion of enrollment in its Phase 3 trial of telitacept in gMG Spyre Therapeutics announced Phase 2 Part A induction results for SPY003 in UC Alebund Pharmaceuticals announced FDA clearance of its IND application for AP308 for the treatment of IgA Nephropathy Greywolf Therapeutics dosed the first participant with axSpA in the Ph1/2 trial of GRWD0715. Vor Bio announced the completion of enrollment in its Phase 3 trial of telitacept in gMG.