FDA approvals - March 2026
New options emerged in PBC-associated itch, plaque psoriasis, neurologic Hunter syndrome, and platinum-resistant ovarian cancer.
Novartis to acquire Excellergy, adding Phase 1 anti-IgE program
Deal brings Exl-111 into Novartis’s allergy portfolio, targeting IgE-driven diseases including food allergy and asthma.
Merck to Acquire Terns, Adding TERN-701 to Hematology Pipeline
Merck has agreed to acquire Terns Pharmaceuticals for $53.00 per share in cash, adding Phase 1/2 CML candidate TERN-701 to its hematology pipeline.
Kali licenses KT501 to Sanofi in autoimmune disease deal
Sanofi will obtain exclusive worldwide rights to Kali Therapeutics’ KT501 under an agreement covering a tri-specific T-cell engager for B cell-mediated autoimmune diseases.
Denali’s AVLAYAH wins FDA accelerated approval in Hunter syndrome
The accelerated approval in Hunter syndrome was supported by Phase 1/2 biomarker data and adds a Priority Review Voucher alongside Denali’s first approved blood-brain barrier-penetrant biologic.
FDA Clears Corcept’s Relacorilant Plus Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer
Corcept’s FDA approval establishes relacorilant as the first FDA-approved selective glucocorticoid receptor antagonist
India semaglutide market sees new moves from Lupin, Zydus, and Sun Pharma
Lupin gained semi-exclusive rights to co-market Zydus’ semaglutide injection in India, while Sun Pharma launched Noveltreat and Sematrinity for chronic weight management and type 2 diabetes.
FDA expands IMCIVREE label to acquired hypothalamic obesity as EMANATE misses primary endpoints
Rhythm Pharmaceuticals said the FDA approved IMCIVREE for acquired hypothalamic obesity, making it the first FDA-approved therapy for the condition.
Abbott completes Exact Sciences deal, expanding diagnostics portfolio in cancer screening
The deal increases Abbott’s exposure to a U.S. cancer screening and precision oncology diagnostics market the company sizes at $60 billion.
Aldeyra receives FDA complete response letter for Reproxalap
The FDA issued a Complete Response Letter for Aldeyra’s reproxalap application in dry eye disease, citing insufficient evidence of efficacy and inconsistent trial results.
Johnson & Johnson’s ICOTYDE brings a new oral IL-23 option to plaque psoriasis
On March 17, 2026, the FDA approved Johnson & Johnson’s ICOTYDE (icotrokinra) for adults and pediatric patients 12 years and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ICOTYDE is a once-daily oral IL-23 receptor antagonist, and Johnson
FDA approves Alfasigma’s Lynavoy for primary biliary cholangitis
On March 17, 2026, the US FDA approved Lynavoy (linerixibat) for cholestatic pruritus associated with primary biliary cholangitis. The approval came days after GSK and Alfasigma announced a March 9 licensing agreement under which Alfasigma acquired exclusive worldwide rights to develop, manufacture, and commercialize linerixibat. Under the agreement, GSK receives
Novartis expands Cosentyx label with FDA approval in adolescent Hidradenitis Suppurativa
The FDA approval extends Cosentyx into pediatric hidradenitis suppurativa, with use supported by adult studies, pharmacokinetic modeling, and pediatric data from other approved indications
China approves commercial BCI system for cervical spinal cord injury patients
The approved NEO system is designed to restore hand-grasping ability through neural signal decoding and a robotic glove.
Lilly escalates compounding challenge after finding impurity in Tirzepatide-B12 products
Eli Lilly said testing found an impurity in compounded tirzepatide products mixed with vitamin B12 and urged FDA action.
Bristol Myers Squibb’s Mezigdomide Delivers Progression-Free Survival Benefit in Phase 3 SUCCESSOR-2 Trial
SUCCESSOR-2 is mezigdomide’s first positive Phase 3 study and the CELMoD program’s second. The trial showed a progression-free survival benefit over carfilzomib and dexamethasone alone.