The U.S. Food and Drug Administration approved an expanded peripheral artery disease indication for Janssen’s Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization due to symptomatic PAD.
The Food and Drug Administration on Aug. 23 approved Cara Therapeutics’ drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making Korsuva the first therapy for the ailment in the United States.
New York City will require public school teachers and staff to get vaccinated against Covid-19, Mayor Bill de Blasio said on Aug. 23, part of a push to get more residents inoculated and slow the spread of the highly contagious Delta variant.
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This is the Food and Drug Administration’s (FDA) tweeted advice to Americans seeking out alternative, unapproved treatments for Covid-19.
The U.S. Food and Drug Administration granted the Pfizer-BioNTech Covid-19 vaccine Comirnaty full approval.
Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
U.S. President Joe Biden’s administration ruled out nominating Janet Woodcock as the permanent head of the Food and Drug Administration, Bloomberg News reported on Aug. 19, citing people familiar with the matter.
The U.S. Food and Drug Administration granted accelerated approval to GlaxoSmithKline’s PD-1 checkpoint inhibitor Jemperli (dostarlimab) for a wider group of indications for adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
The U.S. Food and Drug Administration rejected Sesen Bio’s lead candidate Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer.
The U.S. Food and Drug Administration approved Pfizer’s tick-borne encephalitis vaccine TICOVAC to prevent TBE in people aged 1 year and older.