March 13, 2026
Clinical Updates
Leucovorin – New indication
March 10, 2026 - The FDA announced the approval of Wellcovorin (leucovorin), for the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD).
Clinical Updates
Prezcobix® and Prezcobix PED (darunavir/cobicistat) – Expanded indication, new formulation
February 27, 2026 - The FDA approved Janssen’s Prezcobix (darunavir/cobicistat), in combination with other antiretroviral agents for the treatment of HIV-1 in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
Clinical Updates
Sotyktu™ (deucravacitinib) – New indication
March 6, 2026 - Bristol Myers Squibb announced the FDA approval of Sotyktu (deucravacitinib), for the treatment of active psoriatic arthritis (PsA) in adults.
Clinical Updates
Tecvayli® (teclistamab-cqyv) – New indication, accelerated approval converted to traditional approval
March 5, 2026 - The FDA announced the approval of Johnson & Johnson’s Tecvayli (teclistamab-cqyv), in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj), for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Drug Recalls - Availability
Ipsen – Withdrawal of Tazverik® (tazemetostat) 200 mg tablet
March 9, 2026 - Ipsen announced a voluntary withdrawal of Tazverik (tazemetostat) tablets from the market due to adverse events of secondary hematologic malignancies.