The Vibrant orally administered vibrating capsule (Vibrant Gastro), an FDA-cleared medical device, is now available by prescription for treatment of adults with chronic idiopathic constipation (CIC) who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month. It is the first drug-free treatment to be authorized by the FDA for this indication.

The FDA has approved the second-generation antipsychotic drug cariprazine (Vraylar — Abbvie) for adjunctive treatment of major depressive disorder (MDD) in adults. Cariprazine was previously approved for treatment of schizophrenia and bipolar depression, and for acute treatment of manic or mixed episodes associated with bipolar I disorder.

The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes' duration.

Rosacea is a common, chronic inflammatory facial eruption of unknown cause. It is more prevalent in women than in men, and disease onset typically occurs after age 30. Rosacea is characterized by erythema, telangiectasia, and flushing, and sometimes by recurrent, progressive crops of acneiform papules and pustules, usually on the central part of the face. Some patients develop granulomas and tissue hypertrophy, which may lead to rhinophyma (a bulbous nose), particularly in men. Blepharitis and conjunctivitis are common. Keratitis and corneal scarring occur rarely.

The FDA has approved an intranasal formulation of the opioid antagonist nalmefene (Opvee – Indivior) for emergency treatment of known or suspected opioid overdose in persons ≥12 years old. Nalmefene, which is available by prescription, is the second opioid antagonist to become available as a nasal spray for this indication; the first was naloxone, which is now available for sale over the counter (Narcan, and generic). Other nasal spray formulations of naloxone and injectable formulations of nalmefene and naloxone are available by prescription (see Table 2).

The 0.15% nasal spray formulation of the H₁- antihistamine azelastine hydrochloride (Astepro Allergy; Children's Astepro Allergy – Bayer) is now available over the counter (OTC) for temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to allergic rhinitis in adults and children ≥6 years old. It is the first intranasal antihistamine to be approved by the FDA for OTC use. Other drugs that are available OTC for treatment of allergic rhinitis symptoms include oral antihistamines, intranasal corticosteroids, and mast cell stabilizers.

View the Comparison Table: Some Nasal Sprays for Seasonal Allergic Rhinitis

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...

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....

Penpulimab-kcqx (Anniko – Akeso Biopharma), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin or carboplatin plus gemcitabine for first-line treatment of recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma and for use as monotherapy for metastatic disease in adults with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Penpulimab is the second immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma;...