The oral poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna – Pfizer) has been approved by the FDA for use in combination with the androgen receptor blocker enzalutamide (Xtandi) for treatment of adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug has been available since 2018 for treatment of deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.

Fidanacogene elaparvovec-dzkt (Beqvez – Pfizer), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for treatment of adults with moderate to severe hemophilia B who do not have neutralizing antibodies to AAV serotype Rh74var and currently receive factor IX prophylaxis therapy or have had life-threatening hemorrhage or repeated, serious, spontaneous bleeding episodes. Beqvez is the second single-dose gene therapy to be approved in the US for treatment of hemophilia B; Hemgenix was the first.

The FDA has authorized over-the-counter (OTC) sale of a nonmedicated alcohol-based gel (Eroxon – Futura) for treatment of erectile dysfunction (ED) in males ≥22 years old. Eroxon is the only FDA-approved OTC and topical treatment for erectile dysfunction. It is also available in the UK and the EU.

The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.

A penicillin is the drug of choice for treatment of many infections, but allergic reactions to these drugs occur frequently and, rarely, can be fatal. From 5% to 20% of patients have a history of a rash or some other reaction while taking a penicillin, but maculopapular rashes with ampicillin or amoxicillin, especially in children with infectious mononucleosis, are probably not allergic.

Taking aspirin to prevent recurrence or worsening of cardiovascular disease has become a common practice in recent years (Medical Letter, 28:31, 1986). Now, the US Food and Drug Administration is considering whether aspirin can also be advertised for prevention of a first myocardial infarction in previously healthy people.

Mifepristone (RU 486; Mifeprex - Danco), an antiprogestin, has been approved by the FDA for termination of intrauterine pregnancies of 49 days or less. It is generally used with misoprostol (Cytotec - Searle), an E₁ prostaglandin analog marketed in the USA only for prevention of gastric ulcers.

Budesonide (Entocort EC — AstraZeneca), a locally active glucocorticosteriod widely used for inhalation treatment of allergic rhinitis and asthma (Medical Letter 2000; 42:19), has been approved for oral treatment of mild to moderate active Crohn's disease involving the ileum and/or ascending colon. Both oral budesonide and budesonide enemas have been available for years in Europe and Canada for treatment of inflammatory bowel disease.

Zolmitriptan (Zomig - AstraZeneca) nasal spray was recently approved by the FDA for treatment of migraine. It is the second selective serotonin receptor agonist ("triptan") to become available as a nasal spray; sumatriptan has been available in this form since 1997. Some patients with migraine cannot take tablets because of nausea and vomiting, and nasal sprays are more convenient than subcutaneous injections.

Mecasermin (Increlex - Tercica), which is injected subcutaneously, has been approved by the FDA for treatment of growth failure in children with severe primary insulin-like growth factor (IGF-1) deficiency. Mecasermin is recombinant human (rh) IGF-1. It has also been approved to treat children with short stature who are deficient in growth hormone (GH), but have developed neutralizing antibodies in response to GH treatment. A similar product, mecasermin rinfabate (Iplex - Insmed), that was approved by the FDA for the same indications was withdrawn from the market due to patent...