Cadence Refiles Ofirmev New Drug Application
The NDA for Ofirmev was resubmitted on May 4, 2010. The FDA is expected to determine the type of resubmission (Class 1 or Class 2) and resulting review
The European Commission (EC) has approved an extended use of Johnson & Johnson’s Tecvayli (teclistamab), along with daratumumab, to treat adult patients with relapsed or refractory multiple myeloma (r/r MM).
The 8 non-antibiotic oral formulations licensed to Alvogen under the agreement comprise products in the high growth therapeutic segments of CNS and Osteoporosis among others. Under this agreement,