California Pharmacist Vol. 73, No. 2 SPRING 2026 - Magazine - Page 33
new drugs
FDA Novel Drug Approvals: January–March 2026
Katelyn Dang, Harold Hua, Sarah Kousba, Lana Alamamreh, Alkarrar Salman, Ariel Dong, Ti昀昀any Phung, and
David G. Mitchell
This is a list of selected newly FDA-approved drugs for the most recent quarter. Resources include manufacturer-released
materials, FDA, and IPD Analytics. For more information, please refer to the product labeling for each drug. Other novel
drug approvals are listed on the FDA website.
Therapeutic Area
Medication
What Makes It Novel?
Manufacturer
Date of
Approval
Endocrinology
Zycubo (copper
histidinate)
Zycubo is the 昀椀rst
FDA-approved treatment in the U.S. for pediatric Menkes disease;
it is administered as a
subcutaneous copper
histidinate injection. It
demonstrated rapid onset and targeted mechanism, o昀昀ering more
consistent e昀케cacy with
a potentially favorable
safety pro昀椀le compared
to existing approaches.
Sentynl Therapeutics Inc.
1/12/2026
Dermatology
Adquey (difamilast)
Adquey 1% ointment
is a twice-daily topical phosphodiesterase-4 inhibitor for
mild-to-moderate
atopic dermatitis in patients ≥2 years, o昀昀ering
a practical, steroid-free
option for long-term
use with reduced corticosteroid-related risks.
Acrotech Biopharma
2/12/2026
Behavioral Health
Bysanti (milsaperidone)
Bysanti is a second-generation (atypical) antipsychotic agent
for treating schizophrenia and manic or mixed
episodes of bipolar
I disorder in adults,
o昀昀ering a di昀昀erentiated receptor pro昀椀le
that supports e昀昀ective
symptom control with
a potentially improved
tolerability pro昀椀le.
Vanda Pharmaceuticals Inc.
2/20/2026
California Pharmacist | vol. 73, no. 2
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