The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Zilucoplan is the first complement inhibitor to be approved for treatment of myasthenia gravis that can be self-administered. Two IV complement inhibitors, eculizumab (Soliris) and ravulizumab (Ultomiris), were approved earlier.

The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in adults when IV analgesia is considered clinically necessary. Single-drug IV solutions containing ibuprofen (Caldolor) and acetaminophen have been available in the US for years.

Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso Forte, and generics) for treatment of primary biliary cholangitis (PBC) in adults who had an inadequate response to UDCA and as monotherapy in those unable to tolerate UDCA. Accelerated approval was based on a reduction in alkaline phosphatase (ALP) levels. Seladelpar is the second PPAR agonist to be approved in the US for this indication; elafibranor (Iqirvo)...

The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA has approved a 12.45% gel formulation of the anticholinergic drug sofpironium (Sofdra – Botanix) for treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients ≥9 years old.

Palopegteriparatide (Yorvipath – Ascendis), a parathyroid hormone (PTH) 1-34 analog, has been approved by the FDA for treatment of hypoparathyroidism in adults. The parathyroid hormone analog teriparatide (Forteo, and others), which is approved for treatment of postmenopausal osteoporosis, has been used off-label for treatment of hypoparathyroidism.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%.

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.