The FDA has approved the ophthalmic solutions riboflavin 5'-phosphate in 20% dextran (Photrexa Viscous – Avedro) and riboflavin 5'-phosphate alone (Photrexa) for use with ultraviolet A (UVA) light (KXL System) in the corneal collagen cross-linking treatment of two corneal disorders: progressive keratoconus and corneal ectasia following refractive surgery. It is the first corneal collagen cross-linking (CXL) treatment to be approved by the FDA.

The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

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The FDA has approved the oral tyrosine kinase inhibitor avapritinib (Ayvakit – Blueprint Medicines) for treatment of unresectable or metastatic gastrointestinal stromal tumors (GISTs) harboring a platelet-derived growth factor receptor alpha (PDGFRA) D842V or other PDGFRA exon 18 mutation. Avapritinib is the first drug to be approved for this indication in the US.

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a third dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18 years old (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent (see Table 1).

The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First approved in 2009 for treatment of schizophrenia, iloperidone is the eighth second-generation antipsychotic to be approved for acute treatment of manic or mixed episodes of bipolar I disorder (see Table 1).

A reader of our article on the 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) asked us to provide more information on the data that supported their licensure.

Hypertensive emergencies include hypertensive encephalopathy, intracranial hemorrhage with hypertension, aortic dissection, acute pulmonary edema with hypertension, acute cardiac ischemia with hypertension, malignant hypertension and severe hypertension after vascular surgery; hypertensive crisis due to pheochromocytoma or occurring during pregnancy is not discussed in this review. Although immediate reduction of blood pressure is necessary in hypertensive emergencies, an excessive decrease may cause stroke, myocardial infarction or visual changes. Most experienced clinicians aim...

Combination antiretroviral therapy including protease inhibitors has dramatically changed the treatment of HIV infection and the prognosis of those affected (Medical Letter Handbook of Antimicrobial Therapy, 1998, page 122). Due to limitations and failures with these drugs in many patients, however, three new drugs, none of them protease inhibitors, have rapidly come into wide use in clinical trials or 'expanded access' programs. They are abacavir (Ziagen - Glaxo Wellcome), adefovir (Preveon - Gilead) and efavirenz (Sustiva - DuPont). Efavirenz was recently approved for treatment of...

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) with some cyclooxygenase-2 (COX-2) selectivity in vitro, has been approved by the FDA for treatment of osteoarthritis.