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 Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment

Zealand Pharma, Glepaglutide, GLP-2 analog, Short Bowel Syndrome (SBS), FDA rejection, Complete Response Letter

FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues

Zealand Pharma, dasiglucagon, congenital hyperinsulinism, FDA, Complete Response Letter, third-party manufacturing issues