The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

View the Comparison Table: Some FDA-Approved Drugs for Weight Management

The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is the first selective TYK2 inhibitor to be approved in the US for any indication.

The FDA has approved zavegepant nasal spray (Zavzpret – Pfizer) for acute treatment of migraine with or without aura in adults. Zavzpret is the first nasal spray formulation of a calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant") to become available in the US.

The FDA has approved the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old. Roflumilast is the first PDE4 inhibitor to be approved in the US for this indication. It is also available in a 0.3% cream formulation (Zoryve) for treatment of plaque psoriasis and in an oral formulation (Daliresp, and generics) for treatment of chronic obstructive pulmonary disease. A 0.15% cream formulation for treatment of atopic dermatitis in patients ≥6 years old will be reviewed...

Elafibranor (Iqirvo – Ipsen), a peroxisome proliferator-activated receptor (PPAR) agonist, has been granted accelerated approval by the FDA for treatment of primary biliary cholangitis (PBC) in adults. It is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in patients with an inadequate response to UDCA alone and as monotherapy in those unable to tolerate UDCA.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.