The FDA has approved a 0.75% ophthalmic solution of the alpha-adrenergic antagonist phentolamine (Ryzumvi – Viatris) for treatment of mydriasis produced by adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide in patients ≥3 years old. Ryzumvi is the first drug to be approved in the US for reversal of pharmacologically induced mydriasis.

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old. It is the first topical tetracycline formulation to be approved for use in patients with acne. Oral minocycline (Minocin, Solodyn, and generics) is

The FDA has approved eptinezumab-jjmr (Vyepti – Lundbeck), a calcitonin gene-related peptide (CGRP) antagonist administered IV once every 3 months, for migraine prevention in adults. It is the fourth monoclonal antibody to be approved for this indication; erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality), which are all given subcutaneously once monthly (fremanezumab can also be given once every 3 months), were approved earlier.

The FDA has approved viloxazine extended-release capsules (Qelbree – Supernus) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. Viloxazine is the second selective norepinephrine reuptake inhibitor to be approved in the US for treatment of ADHD; atomoxetine (Strattera, and generics) was approved in 2002.

The FDA has approved ponesimod (Ponvory – Janssen), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Ponesimod is the fourth oral S1P receptor modulator to be approved in the US for once-daily treatment of relapsing forms of MS; ozanimod (Zeposia) and siponimod (Mayzent) are also approved for use in adults, and fingolimod (Gilenya) is indicated for use in patients...

The FDA has approved ibrexafungerp (Brexafemme – Scynexis), a first-in-class triterpenoid antifungal ("fungerp"), for oral treatment of vulvovaginal candidiasis in postmenarchal females.

The FDA has approved Trudhesa (Impel Neuropharma), a new dihydroergotamine nasal spray product, for acute treatment of migraine with or without aura in adults. Another dihydroergotamine nasal spray (Migranal, and generics) has been available for many years for the same indication.

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.