The FDA's warning about Xeljanz (tofacitinib) and other JAK inhiitors and the extension of its review of Janssen's CAR T therapy for multiple myeloma were among the best read articles about the agency in 2021.
Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin.
The FDA didn’t have enough data to assess the risks and benefits of Zyesami.
The agency needs more time to review new information on the analytical method used.
The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious cardiovascular events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.
New requirements resulted in long call wait times, which has led to patient access issues.