Atacept (Orencia - Bristol-Myers Squibb), an inhibitor of T-cell activation, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA) in patients who have not responded to one or more disease-modifying anti-rheumatic drugs (DMARDs).

The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.

The FDA has approved an oral powder formulation of the amino acid L-glutamine (Endari – Emmaus) to reduce the acute complications of sickle cell disease in patients ≥5 years old. Endari is only the second drug to be approved for use in sickle cell disease; the antimetabolite hydroxyurea (Droxia) was approved 20 years ago. L-glutamine oral powder is also available by prescription as NutreStore for treatment of short bowel syndrome and over the counter as a dietary supplement.

The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.

The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H₃)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H₃-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.

The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).

The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes. Two other pneumococcal vaccines are available in the US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate vaccine licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23; Merck), a 23-valent pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years...

Rofecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis, acute pain and menstrual pain.

The FDA has approved the use of tranexamic acid (Lysteda – Ferring), an oral antifibrinolytic, for treatment of menorrhagia. Tranexamic acid has been used for this purpose in Europe for decades, and is available without a prescription in some countries. It has been available in the US since 1987 for use with coagulation factors in patients with hemophilia undergoing dental extractions.

The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human monoclonal antibody, for treatment of adults with moderate to severe atopic dermatitis (eczema) that has not responded to topical therapies. It can be used with or without topical corticosteroids.