Shots:
- Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.
- Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia
- Overall, February 2026 reflected sustained FDA focus on meaningful clinical benefit, spanning common inflammatory disease to high-unmet-need rare conditions.
Company: Acrotech Biopharma and Otsuka Pharmaceuticals
Product: Adquey
Active Ingredient: Difamilast
Disease: Mild-to-Mod. Atopic Dermatitis
Date: Feb 12, 2025
Shots:
- The US FDA has approved Adquey (difamilast 1%) ointment for treating mild-to-mod. atopic dermatitis in adults and children aged≥ 2 yrs.
- Approval was based on multiple pivotal P-III trials, which showed a significantly higher proportion of patients treated with ADQUEY achieving IGA success after 4 wks vs vehicle, with a consistent safety profile
- ADQUEY is a non-steroidal topical PDE-4 inhibitor for BID treatment of mild-to-mod. atopic dermatitis in patients aged ≥2 years, inhibiting all PDE-4 subtypes. Difamilast was discovered by Otsuka Pharmaceutical and licensed to Acrotech Biopharma in the U.S. in 2021
Company: Vanda Pharmaceuticals
Product: Bysanti
Active Ingredient: Milsaperidone
Disease: Acute Bipolar I Disorder & Schizophrenia
Date: Feb 20, 2025
Shots:
- FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26
- In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full therapeutic dose range, allowing it to rely on the established efficacy & safety profile from extensive development data & 100,000+ patient-years of RWE with Fanapt
- Also, Bysanti (QD) is being assessed as adjunctive therapy for treatment-resistant major depressive disorder, with trial expected to complete by the end of 2026
Company: Immedica Pharma
Product: Loargys
Active Ingredient: Pegzilarginase-nbln
Disease: Hyperargininemia in Patients with ARG1-D
Date: Feb 23, 2025
Shots:
- The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in pts (≥2yrs.) with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction, with commercial availability expected in Apr 2026
- Approval was based on the P-III (PEACE) trial assessing Loargys vs PBO, which showed reduced plasma arginine from baseline at 24wks.
- Additionally, Immedica is launching There for Rare, a patient support program offering nonmedical education & financial assistance guidance to enhance access for eligible individuals prescribed Loargys
Company: Ascendis
Product: Yuviwel
Active Ingredient: Navepegritide
Disease: Achondroplasia
Date: Feb 27, 2025
Shots:
- FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26
- Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics
- Continued approval may require confirmatory trials to verify clinical benefit beyond AGV improvement, and the FDA also granted a Rare Pediatric Disease PRV with the approval
Related Post: Insights+: The US FDA New Drug Approvals in January 2025
