The FDA has approved the second-generation antipsychotic drug cariprazine (Vraylar — Abbvie) for adjunctive treatment of major depressive disorder (MDD) in adults. Cariprazine was previously approved for treatment of schizophrenia and bipolar depression, and for acute treatment of manic or mixed episodes associated with bipolar I disorder.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.

Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.

Tyrvaya (Oyster Point), a nasal spray formulation of the cholinergic agonist varenicline, has been approved by the FDA for treatment of dry eye disease. It is the first nasal spray to be approved in the US for this indication. An oral formulation of varenicline (Chantix, and generics) has been available for years for smoking cessation.

The FDA has amended its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of bivalent formulations of the products as a single booster dose in persons ≥12 years old (Pfizer) or ≥18 years old (Moderna) whose most recent COVID-19 vaccine dose was a monovalent product given ≥2 months previously as a booster or for completion of a primary series. The bivalent formulations are not authorized for primary immunization. Monovalent Pfizer and Moderna COVID-19 vaccines are no longer...

The FDA has approved Xacduro (Innoviva), a combination of the beta-lactam antibacterial sulbactam and the beta-lactamase inhibitor durlobactam, for IV treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC).

Avmapki Fakzynja Co-Pack (Verastem), a combination of the kinase inhibitors avutometinib and defactinib, has received accelerated approval from the FDA for treatment of KRAS-mutated recurrent low-grade serous ovarian cancer in women who had previously received systemic therapy. Neither drug is approved for use as monotherapy for any indication. Avmapki Fakzynja is the first treatment to be approved in the US for this indication.

The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6 months in patients who require ongoing protection against COVID-19. Evusheld is authorized for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise

The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use Authorization (EUA) for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise.

The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency's requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.