The FDA has approved Otovel (Arbor), a combination of the fluoroquinolone antibiotic ciprofloxacin 0.3% and the corticosteroid fluocinolone acetonide 0.025%, for otic treatment of acute otitis media with tympanostomy tubes (AOMT) in children ≥6 months old. It is the second fluoroquinolone/corticosteroid combination to be approved for this indication; ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex) has been available for many years. In December 2015, a suspension of ciprofloxacin 6% (Otiprio) was approved for otic treatment of bilateral otitis media with effusion in children...

View the Expanded Table: Drugs for Prophylaxis of Malaria

Tofersen (Qalsody – Biogen), an intrathecally administered antisense oligonucleotide, has received accelerated approval from the FDA for treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. About 2% of patients with ALS have mutations in the SOD1 gene. Tofersen is the first drug to be approved in the US that targets a genetic cause of ALS. Accelerated approval of the drug was based on the surrogate endpoint of a reduction in plasma neurofilament light chain, which is considered likely to predict clinical...

Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also been approved for use in conjunction with food allergen avoidance to reduce IgE-mediated food allergic reactions caused by accidental exposure in patients ≥1 year old. Omalizumab is the first drug to be approved in the US to reduce allergic reactions to more than one food. Palforzia, an oral peanut allergen powder, was approved in 2020 to mitigate allergic reactions caused by...

Recent studies suggest that timely use of automated external defibrillators operated by laypersons with minimal training can save lives. Purchase of these devices for public places or home use requires authorization from a physician.

Opioids, benzodiazepines, propofol, antipsychotics and dexmedetomidine (Precedex) are frequently used in the intensive care unit (ICU) to manage pain, anxiety, agitation and delirium, and to facilitate procedures such as mechanical ventilation. The use of dexmedetomidine, a centrally-acting selective α₂-receptor agonist approved by the FDA in 1999, has been increasing in recent years. Some new studies comparing it to other drugs for ICU sedation have been published.

The recent increase in deaths due to overdose of heroin and prescription opioids in the US has renewed interest in the opioid antagonist naloxone, particularly in making it available to first responders and to relatives and close friends of persons using heroin or taking prescription opioids. IV or IM administration by healthcare professionals is preferred, but peripheral venous access may be difficult to obtain in IV drug abusers, and exposure to their blood may be hazardous.

The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

The results of the recently published FOURIER trial have shown a reduction in cardiovascular events with addition of the PCSK9 inhibitor evolocumab (Repatha) to statin therapy in patients with atherosclerotic cardiovascular disease (ASCVD).

Unlike new drugs, new techniques for surgery do not need the approval of any government agency. Laparoscopic cholecystectomy, made possible by the development of miniaturized television cameras, is one such technique that has recently attracted widespread interest (LW Way, N Engl J Med, 323:1273, Nov 1, 1990; R Winslow, Wall St J, 216:1, Dec 10, 1990).