Tag Archive for: supplemental Biologics License Application

The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.

The FDA has granted Priority Review to Sanofi and Regeneron’s supplemental Biologics License Application seeking to expand its blockbuster antibody therapeutic Dupixent (dupilumab) into chronic obstructive pulmonary disease, the companies announced Friday.

After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.

Bristol Myers Squibb and 2seventy bio published positive results Friday from a pivotal trial of their B-cell maturation antigen–directed (BCMA) CAR T-cell therapy in multiple myeloma patients who had received two to four prior lines of therapy.