The oral kinase inhibitor futibatinib (Lytgobi – Taiho) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Accelerated approval was based on the overall response rate and duration of response. Futibatinib is the second drug to be approved for this indication; pemigatinib (Pemazyre) was approved earlier.

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

The FDA has approved Inlexzo, a gemcitabine intravesical system, for treatment of Bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. The Inlexzo system is placed into the bladder to deliver gemcitabine for 3 weeks.

Nerandomilast (Jascayd – Boehringer Ingelheim), an oral phosphodiesterase 4 (PDE4) inhibitor, has been approved by the FDA for treatment of idiopathic pulmonary fibrosis (IPF) in adults. It is the third drug to be approved in the US for this indication; the oral antifibrotic drugs pirfenidone (Esbriet, and generics) and nintedanib (Ofev) were approved in 2014.

The FDA has expanded the licensed use of the recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) to include adults 18-49 years old. Arexvy and the two other available RSV vaccines, Abrysvo and mResvia, are now all licensed for prevention of RSV lower respiratory tract disease in persons ≥60 years old and in those 18-59 years old who are at increased risk of lower respiratory tract disease caused by RSV. Abrysvo is also licensed for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated lower respiratory tract disease in their infants from birth to...

Relacorilant (Lifyorli – Corcept Therapeutics), an oral first-in-class glucocorticoid receptor antagonist, has been approved by the FDA for use in combination with nab-paclitaxel (Abraxane, and generics) for treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy, one of which included bevacizumab (Avastin, and others).

The FDA has warned that prolonged use of a proton pump inhibitor (PPI) can lead to hypomagnesemia.1 Normal serum concentrations of magnesium are 0.7-1.0 mmol/L. About 30 cases of severe hypomagnesemia (<0.5 mmol/L) have been reported in long-term PPI users; when the PPI was stopped, serum magnesium levels returned to normal in less than 2 weeks.2-5 The exact mechanism is unknown, but in some patients PPIs apparently interfere with active transport of magnesium across the intestinal wall or cause excessive loss into the intestinal lumen.6 Hypomagnesemia is often accompanied by hypocalcemia...

A reader commenting on our Treatment of Lyme Disease article (Med Lett Drugs Ther 2016; 58:57) objected to a footnote in the table advising against use of doxycycline in children <8 years old. This warning has been included in the labeling of all tetracyclines since 1970 when it was recognized, after decades of use, that these drugs caused permanent staining and enamel hypoplasia of developing teeth. The CDC recently stated that short courses of doxycycline, which was first marketed in the US in 1967 and has less affnity for calcium than other tetracyclines, have not been shown to cause...

Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning about the risks of uterine and fallopian tube perforation, migration of the device to the abdominal or pelvic cavity, persistent pain, and hypersensitivity reactions. Some women were apparently not being informed of these risks before implantation of...

Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.