Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors...

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options. The combination is not approved for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition and dabrafenib is not approved for use in patients with wild-type BRAF...

Colchicine (Colcrys, and others), which has been available in the US for decades for prophylaxis and treatment of gout flares and other indications in oral formulations that contain 0.6 mg of the drug, has now been approved in 0.5-mg tablets as Lodoco (Agepha) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple risk factors for cardiovascular disease.

The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...

The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. Repotrectinib is the third oral tyrosine kinase inhibitor to be approved for this indication in the US; crizotinib (Xalkori) and entrectinib (Rozlytrek) were approved earlier.

The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Donislecel is the first cell-based treatment to be approved in the US for type 1 diabetes.

The FDA has approved the intravenously administered beta₁-adrenergic blocker landiolol (Rapiblyk – AOP) for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Esmolol (Brevibloc, and generics), another IV beta blocker, was approved earlier for the same indication.

Clopidogrel (Plavix - Sanofi-Aventis and Bristol-Myers Squibb), an oral thienopyridine that inhibits platelet aggregation, is now being advertised directly to the public on television. Clopidogrel is approved by the FDA for secondary prevention of myocardial infarction (MI), stroke and other vascular events and for use in patients with acute coronary syndrome (unstable angina or non-ST-elevation MI), including those undergoing angioplasty. It is used off-label for patients with ST-elevation acute MI

Aliskiren (ah LIS ker in; Tekturna - Novartis), the first direct renin inhibitor, has been approved by the FDA for treatment of hypertension. It is indicated for oral use either as monotherapy or in combination with other antihypertensive agents.

The FDA has approved two subcutaneously injected calcitonin gene-related peptide (CGRP) antagonists, fremanezumab-vfrm (Ajovy – Teva) and galcanezumab-gnlm (Emgality – Lilly), for migraine prevention in adults. Fremanezumab and galcanezumab are the second and third subcutaneously injected monoclonal antibodies that target the CGRP pathway to be approved by the FDA for this indication; erenumab-aooe (Aimovig), which targets the CGRP receptor, was the first.