The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. Mobocertinib is the second drug to become available in the US for this indication; the IV EGFR-MET bispecific antibody amivantamab (Rybrevant) was approved...

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV 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). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

The injectable interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) is now FDA-approved for treatment of moderately to severely active Crohn's disease (CD) in adults. Mirikizumab was approved in 2023 for treatment of ulcerative colitis. Two other IL-23 antagonists, risankizumab (Skyrizi) and guselkumab (Tremfya), are also approved for treatment of CD.

The FDA has approved changes to the wording of the cardiovascular risk reduction indications for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab (Repatha) and alirocumab (Praluent). Both drugs are now approved to reduce the risk of major adverse cardiovascular events (MACE) in adults at increased risk for these events; they were previously approved to reduce the risk of MACE only in patients with established cardiovascular disease (CVD).

The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.

The subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) has been approved by the FDA for treatment of chronic spontaneous urticaria in patients ≥12 years old who remain symptomatic despite H₁-antihistamine treatment. Dupilumab was approved earlier for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease with an eosinophilic phenotype.

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.

Zurnai (Purdue), an autoinjector formulation of the opioid antagonist nalmefene, has been approved by the FDA for intramuscular (IM) or subcutaneous (SC) emergency treatment of known or suspected opioid overdose in persons ≥12 years old. Naloxone, another opioid antagonist, has been available in single-use syringes for years. Both nalmefene and naloxone are also available in nasal sprays; some naloxone nasal sprays (Narcan, and others) are available over the counter.

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.