California Pharmacist Winter 2026 - Flipbook - Page 33
new drugs
FDA Novel Drug Approvals: September–December 2025
Carson Potter, Vincent Nguyen, Stephen Lau, Mina Kamal, Irana Keshvari, 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
Hematology
Wayrilz
(Rilzabrutinib)
Wayrilz is a novel oral, reversible Bruton’s tyrosine kinase
(BTK) inhibitor for adults with
persistent or chronic immune
thrombocytopenia (ITP). It is
the 昀椀rst BTK inhibitor approved
for this indication, addressing
the root causes of ITP through
multi-immune modulation.
Sano昀椀
8/29/2025
Oncology
Keytruda Qlex
(pembrolizumab)
IV to SQ, healthcare provider
administered in clinic; Keytruda Qlex was previously FDA
approved in the subcutaneous
formulation.
Merck
9/19/2025
Neurology
Forzinity
(Elamipretide)
Forzinity received accelerated
FDA approval in September
2025 for Barth syndrome
(BTHS), a rare mitochondrial
disease, and works by targeting
mitochondrial cardiolipin to
improve mitochondrial function.
Forzinity is the 昀椀rst approved
therapy for BTHS. This medication helps to improve muscle
strength in adult and pediatric
patients with BTHS weighing
≥30 kg.
Stealth Biotherapeutics
9/19/2025
Oncology
Inluriyo
(Imlunestrant)
Inluriyo is an oral selective
estrogen receptor degrader
approved to treat adults with
ER-positive, HER2-negative,
ESR1-mutated advanced
or metastatic breast cancer
resistant to endocrine therapy.
It represents a new hormonal
therapy speci昀椀cally targeting
ESR1 mutations.
Lilly
9/25/2025
Endocrinology
Palsonify
(paltusotine)
Palsonify is an oral somatostatin receptor type 2 agonist
approved for adults with acromegaly who had an inadequate
response to surgery. It is a
nonpeptide agonist with high
selectivity for somatostatin 2
receptors. Palsonify o昀昀ers the
昀椀rst once-daily, oral option in
the category.
Crinetics
9/25/2025
Immunology
Rhapsido (remibrutinib)
Rhapsido is an oral BTK inhibitor
indicated for chronic spontaneous urticaria. It is the 昀椀rst-inclass agent marketed for this
indication.
Novartis
9/30/2025
California Pharmacist | vol. 73, no. 1
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