Ashwagandha is an herb extracted from the roots of an evergreen shrub (Withania somnifera) found in India that has been used as a "tonic" for centuries. No specific constituent has been identified as an active ingredient. Herbal supplements containing ashwagandha, which is also known as winter cherry and Indian ginseng, are widely promoted now in the US for treatment of pain, anxiety, stress, fatigue, sleep disturbances, cognitive decline, diabetes, arthritis, male infertility, and various cancers.

A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.

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.

Low-intensity extracorporeal shockwave therapy similar to that used to fragment kidney stones or gallstones is a new option for treatment of erectile dysfunction that is now being advertised extensively in the US. It has not been approved by the FDA for treatment of erectile dysfunction.

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.

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.

Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion in adults who had disease progression on or after prior systemic therapy. It is the first drug to be approved in the US for treatment of NRG1-positive cancers. Accelerated approval of zenocutuzumab was based on the overall response rate and duration of response.

View the Comparison Chart: Some Drugs for Abdominal Pain in Irritable Bowel Syndrome (IBS)