The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19 vaccine. The mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are preferred for all persons without a contraindication.

Nogapendekin alfa inbakicept-pmln (Anktiva – ImmunityBio), a first-in-class interleukin-15 (IL15) receptor agonist, has been approved by the FDA for use with Bacillus Calmette-Guérin (BCG) for treatment of patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. Such patients generally undergo bladder tumor resection, followed by intravesical BCG treatment, but treatment failure and cancer recurrence are common. The adenoviral vector-based intravesical gene therapy nadofaragene firadenovec-vncg (Adstiladrin)...

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 Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

The FDA has approved Acuvue Theravision with Ketotifen (Johnson & Johnson Vision Care), a daily-wear, disposable, vision-correcting soft contact lens that releases the H₁-antihistamine ketotifen, for prevention of ocular itch due to allergic conjunctivitis in contact lens users. This is the first approval for a drug-eluting contact lens. Ketotifen eye drops (Alaway, Zaditor, and others) are available over the counter.

Atezolizumab (Tecentriq – Genentech), an immune checkpoint inhibitor, has been approved by the FDA for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients ≥2 years old. It was previously approved for treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular cancer, and melanoma (see Table 1). Atezolizumab is the first drug to be approved in the US for treatment of ASPS. ASPS is a rare disorder that affects mostly adolescents and young adults; <1% of soft tissue sarcomas are ASPS.

Risdiplam (Evrysdi – Genentech), a survival of motor neuron 2 (SMN2) splicing modifier, has been approved by the FDA for oral treatment of spinal muscular atrophy (SMA) in patients ≥2 months old. It is the first oral drug to be approved in the US for treatment of SMA; nusinersen (Spinraza), an intrathecally administered SMN2-directed antisense oligonucleotide, and onasemnogene abeparvovec (Zolgensma), an IV adeno-associated virus vector-based gene therapy, were approved earlier.

Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2 infection ("long COVID").