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Best Read Articles on FDA News in 2021
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.
FDA approves sNDAs for Vazalore
Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin.
FDA Rejects EUA for COVID-19 Respiratory Failure Therapy
The FDA didn’t have enough data to assess the risks and benefits of Zyesami.
FDA Extends Review of Janssen’s CAR T Therapy for Multiple Myeloma
The agency needs more time to review new information on the analytical method used.
FDA’s New Warning Includes Xeljanz, Other JAK Inhibitors
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.
FDA Pauses Clozapine REMS Program
New requirements resulted in long call wait times, which has led to patient access issues.
Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
