The FDA has approved an extended-release intramuscular suspension formulation of the gonadotropin-releasing hormone (GnRH) agonist triptorelin (Triptodur – Arbor/Debiopharm) for twice-yearly treatment of central precocious puberty (CPP) in children ≥2 years old. Triptorelin has been available in the US for years as Trelstar for palliative treatment of advanced prostate cancer. Before the approval of Triptodur, Trelstar was used off-label for treatment of CPP.

The investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of confirmed or suspected COVID-19 in hospitalized patients ≥2 years old who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); the EUA requires that baricitinib be used in combination with the IV antiviral drug remdesivir (Veklury). Baricitinib has been available for treatment of rheumatoid arthritis since 2018. Remdesivir was recently approved by the FDA for treatment of COVID-19 in...

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.

Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.

Fensolvi (Tolmar), a long-acting subcutaneous formulation of the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate, has been approved by the FDA for treatment of central precocious puberty (CPP) in children ≥2 years old. It is the first formulation of the drug to be approved for SC administration once every 6 months. IM formulations of leuprolide acetate, which are given once monthly or every 3 months, and the GnRH agonists histrelin acetate (Supprelin LA) and triptorelin (Triptodur) have been available for years for treatment of CPP.

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD) dementia. Donepezil is the second acetylcholinesterase inhibitor to become available in a transdermal formulation; transdermal rivastigmine (Exelon Patch), which is applied once daily, has been available for years for the same indication. Donepezil is also available in oral formulations (Aricept, and generics) for treatment of AD dementia.

The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from the market in 2008 for commercial reasons.