A reader asked us to review use of the phosphodiesterase-5 (PDE5) inhibitor sildenafil for treatment of Alzheimer's disease (AD).

The short-acting formulation of mixed amphetamine salts (Adderall, and generics) FDA-approved for treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently in short supply in the US. Until an adequate supply is restored, patients may be looking for alternatives.

The FDA has approved lutetium lu 177 vipivotide tetraxetan (Pluvicto – Novartis) for treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adults previously treated with androgen receptor (AR) pathway inhibitors and taxane-based chemotherapy.

Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive factor IX prophylaxis therapy or have had life-threatening or repeated, serious, spontaneous bleeding episodes. It is the first gene therapy to be approved in the US for this indication.

Akeega (Janssen), a fixed-dose combination of the oral poly(ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula) and the antiandrogen abiraterone acetate (Zytiga, and others), has been approved by the FDA for use in combination with prednisone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Niraparib has been available since 2017 for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. Abiraterone acetate has been available since 2011 for treatment of CRPC...

Glucagon-like peptide-1 (GLP-1) receptor agonists and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro) are widely prescribed for treatment of type 2 diabetes and weight management (see Table 1), but they delay gastric emptying and commonly cause nausea and vomiting. Gastroparesis and bowel obstruction (ileus) have also been reported with their use.

The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

Afamitresgene autoleucel (Tecelra – Adaptimmune), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy and are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. It is the first gene therapy to be approved in the US for treatment of synovial sarcoma. Accelerated approval of the immunotherapy was based on the...

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).