hydrochloride (Ticlid - Syntex), a platelet aggregation inhibitor that has been available in Europe for more than a decade, was recently approved by the U.S. Food and Drug Administration to decrease the risk of thrombotic stroke in men and women who have had premonitory signs of stroke or have had a completed thrombotic stroke. The manufacturer is promoting the drug for patients intolerant to aspirin or with conditions for which aspirin has not been approved (previous thrombotic stroke; transient ischemic attacks in women). The drug has also been used for prevention of myocardial ...

Rebetron, a combination of injected recombinant interferon alfa-2b with oral ribavirin has been approved by the FDA for treatment of chronic hepatitis C virus infection.

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.

The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local and systemic adverse effects have limited their use.

Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations who had disease progression on or after at least one prior line of systemic therapy. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death receptor-1) or PD-L1 (programmed death-ligand 1) inhibitor therapy. Erdafitinib is the first oral FGFR kinase inhibitor to be...

Readers have inquired about the effectiveness and safety of operations on the cornea to correct refractive errors and restore normal vision without glasses or contact lenses. Several different operations are now being used for this purpose.

The FDA has approved pegaptanib sodium (Macugen - Pfizer/Eyetech) as an intravitreous injection for treatment of all subtypes of neovascular (wet) age-related macular degeneration (AMD). The only other approved treatment for this condition is photodynamic therapy with intravenous verteporfin (Visudyne), which is recommended only for patients with one subtype (predominantly classic) of neovascular AMD.

The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor vemurafenib (Zelboraf) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

The US Food and Drug Administration recently approved the marketing of G-CSF (recombinant human granulocyte colony-stimulating factor, generic name filgrastim, Neupogen - Amgen) and GM-CSF (recombinant human granulocyte-macrophage colony-stimulating factor, generic name sargramostim, Leukine - Immunex, Prokine - Hoechst-Roussel). G-CSF is approved for use after cancer chemotherapy in patients with non-myeloid malignancies to decrease the incidence of infection. GM-CSF is approved for acceleration of myeloid recovery after autologous bone marrow transplantation in non-Hodgkin's lymphoma,...

The FDA has approved letermovir (Prevymis – Merck), a cytomegalovirus (CMV) DNA terminase complex inhibitor, for prophylaxis of CMV infection and disease in CMV-seropositive adult recipients of an allogeneic hematopoietic cell transplant (HCT). Letermovir is the first CMV DNA terminase complex inhibitor to be approved in the US and the only drug specifically indicated for CMV prophylaxis in HCT patients. It is not approved for treatment of CMV infection.