The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Zilucoplan is the first complement inhibitor to be approved for treatment of myasthenia gravis that can be self-administered. Two IV complement inhibitors, eculizumab (Soliris) and ravulizumab (Ultomiris), were approved earlier.

The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in adults when IV analgesia is considered clinically necessary. Single-drug IV solutions containing ibuprofen (Caldolor) and acetaminophen have been available in the US for years.

The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved earlier for treatment of plaque psoriasis and psoriatic arthritis. Guselkumab is the third IL-23 antagonist to be approved in the US for treatment of UC; risankizumab (Skyrizi) and mirikizumab (Omvoh) were approved earlier.

The FDA has approved clesrovimab-cfor (Enflonsia – Merck), a long-acting monoclonal antibody, for prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants born during or entering their first RSV season. Clesrovimab is the second drug to be approved for this indication; nirsevimab (Beyfortus), another long-acting monoclonal antibody, was the first. Palivizumab (Synagis), a shorter-acting antibody, is FDA-approved for prevention of severe RSV LRTI in certain high-risk children ≤24 months old.

The FDA has approved the neonatal Fc receptor (FcRn) blocker nipocalimab (Imaavy – Janssen) for IV treatment of generalized myasthenia gravis (gMG) in patients ≥12 years old with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The FcRn blocker rozanolixizumab (Rystiggo) was approved earlier for the same indication.

Evidence of waning immunity by 5 years post-vaccination has led the US Advisory Committee on Immunization Practices (ACIP) to recommend, in addition to a primary dose of meningococcal conjugate vaccine at 11 or 12 years of age, a booster dose at age 16. Adolescents who receive a first dose of the vaccine at age 13-15 should receive a booster dose at 16-18 (before college). Those who receive their first dose at ≥16 years of age do not need a booster dose. Routine vaccination of healthy persons who are not at increased risk for exposure to Neisseria meningitidis is not recommended after age...

The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the risk of cardiovascular (or unknown cause) death, myocardial infarction, or stroke.21. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes...

Relyvrio, the fixed-dose combination of sodium phenyl-butyrate and taurursodiol that received accelerated approval for treatment of amyotrophic lateral sclerosis (ALS) in 2022 based on a phase 2 trial showing that it slowed functional decline, has voluntarily been withdrawn from the market. According to the manufacturer (Amylyx), the decision to withdraw Relyvrio was based on the results of a phase 3, 48-week trial (PHOENIX). The change from baseline on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, which measures fine motor, gross motor, bulbar, and respiratory...

The FDA has announced that prescribers, pharmacies, and patients are no longer required to participate in a Risk Evaluation and Mitigation Strategy (REMS) program for the second-generation antipsychotic drug clozapine (Clozaril, and others).

Ifosfamide (Ifex - Mead Johnson), a synthetic analog of cyclophosphamide (Cytoxan; and others), has been approved by the US Food and Drug Administration (FDA) for concurrent use with other drugs in third-line chemotherapy of metastatic germ-cell testicular cancer. Given concomitantly, a synthetic sulfhydryl compound known as mesna (Mesnex - Asta) acts in the urine to detoxify metabolites of ifosfamide that cause hemorrhagic cystitis (H Burkert, Cancer Treat Rev, 10 suppl A:175, 1983). Ifosfamide and mesna are available together from Bristol-Myers Oncology Division.