March 27, 2026
Clinical Updates
Imcivree® (setmelanotide) – New indication
March 19, 2026 - Rhythm Pharmaceuticals announced the FDA approval of Imcivree (setmelanotide), to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity (HO).
Clinical Updates
Opdivo® (nivolumab) – New indication, accelerated approvals converted to traditional approvals
March 20, 2026 - The FDA announced the approval of Bristol Myers Squibb’s Opdivo (nivolumab), in combination with doxorubicin, vinblastine, and dacarbazine (AVD), for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).
Drug Approvals
Atoncy™ (atomoxetine) – New drug approval
March 20, 2026 - The FDA approved Validus Pharmaceuticals’ Atoncy (atomoxetine) oral solution, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients 6 years of age and older.
Drug Approvals
Icotyde™ (icotrokinra) – New drug approval
March 18, 2026 - Johnson & Johnson announced the FDA approval of Icotyde (icotrokinra), for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.
Drug Approvals
Lynavoy (linerixibat) – New orphan drug approval
March 19, 2026 - GSK announced the FDA approval of Lynavoy (linerixibat), for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.
Drug Approvals
Wegovy® HD (semaglutide) injection – New formulation approval
March 19, 2026 - Novo Nordisk announced the FDA approval of Wegovy HD (semaglutide) injection 7.2 mg, in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults.
Drug safety
Carbidopa/levodopa – FDA requires warning for vitamin B6 deficiency and associate seizures
March 20, 2026 - The FDA notified all application holders of products containing carbidopa/levodopa that it is requiring the addition of a warning, and corresponding revisions, to the prescribing information to state that these medications can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures.
New Generics
Savella® (milnacipran) – First-time generic
March 19, 2026 - Camber and Breckenridge launched AB-rated generic versions and Glenmark launched an alternative brand alternative of AbbVie’s Savella (milnacipran) tablets.