Response Letter
Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information
Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission
FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence
FDA; Rexulti; Lundbeck; Otsuka; PTSD; brexpiprazole; sertraline; Complete Response Letter; sNDA; clinical trials; drug approval
FDA Rejects Scholar Rock’s SMA Drug Due to Catalent Indiana Manufacturing Issues
FDA; Scholar Rock; Apitegromab; SMA; Spinal Muscular Atrophy; Catalent Indiana; Complete Response Letter; Manufacturing issues; Drug approval
Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy
Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval
Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application
Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop
FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma
FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy
FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues
FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay