California Pharmacist Vol. 73, No. 3 SUMMER 2026 - Magazine - Page 36
new drugs
FDA Novel Drug Approvals: April–June 2026
Emily Hom, Christine Corpuz, Theresa Zheng, Sarah Y. Kye, 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
Foundayo
(orforglipron)
Orforglipron is the 昀椀rst oral GLP-1
receptor agonist that can be taken at
any time of day, with or without food
or water. It is approved by the FDA
to reduce excess body weight and
maintain long-term weight reduction in adults with obesity or adults
who are overweight with at least
1 weight-related comorbidity. It is
used alongside a reduced-calorie
diet and increased physical activity.
Lilly.
4/1/2026
Infectious Disease
Idvynso (doravirine and islatravir)
This 2-drug combination contains
doravirine, a non-nucleoside reverse
transcriptase inhibitor, and islatravir,
a nucleoside reverse transcriptase
inhibitor, is approved for adults with
virologically suppressed HIV-1 with
no prior virologic failure and no
known doravirine-resistance substitutions. It is the 昀椀rst and only non-integrase strand transfer inhibitor,
tenofovir-free, once-daily regimen
proven noninferior to the 3-drug
regimen Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) in
a head-to-head phase 3 trial.
Merck
4/20/2026
In昀氀ammatory
Conditions
Saphnelo SC
(anifrolumab-fnia)
Anifrolumab-fnia is a once-weekly,
self-administered product with an
autoinjector. It is approved for adults
with moderate-to-severe systemic
lupus erythematosus who are receiving other anti-lupus medicines.
The subcutaneous administration
option o昀昀ers added convenience by
allowing patients to manage their
treatment where and how it works
best for them. Anifrolumab-fnia
o昀昀ers the potential to reduce disease
activity and steroid use.
AstraZeneca
4/24/2026
