FDA Alerts

The US Food and Drug Administration recently approved a new treatment option for patients with relapsed or refractory acute myeloid leukemia who have IDH2 mutations.

To address growing public health concerns, the US Food and Drug Administration is designing a new plan to serve as a roadmap for regulating tobacco products in the future, in order to reduce smoking...

The FDA has expanded the approval of an intravenous injection for the treatment of metastatic or unresectable melanoma to include use in pediatric patients.

The US Food and Drug Administration has approved the first subcutaneous self-infection treatment option for patients with active SLE.

After clinical trials demonstrated its efficacy and safety, the FDA has approved a new treatment option for patients with chronic hepatitis C virus without cirrhosis or with mild cirrhosis.

The US Food and Drug Administration recently approved a new treatment option for patients with early stage HER2-overexpressed/amplified breast cancer. For recommended dosage and common adverse events, read...

After clinical trials demonstrated its efficacy, the US Food and Drug Administration approved a biologic therapy for the treatment of patients with moderate to severe plaque psoriasis.

After clinical trials demonstrated a superior overall survival compared with standard care, the US Food and Drug Administration granted full approval to Blincyto.

The US Food and Drug Administration recently approved a new oral treatment for adult and pediatric patients with sickle cell disease.

Following an FDA-issued withdrawal request, an abuse-deterrent opioid will be removed from the market.