FDA Alerts

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.

After several studies demonstrated its efficacy, the FDA expanded the approval of the DigniCap Cooling System to prevent hair loss during chemotherapy to other cancer patients.

The FDA has approved a new option for the treatment of central precocious puberty.

The first-and-only fully human monoclonal anti-epidermal growth factor receptor antibody for the treatment of wild-type RAS metastatic colorectal cancer was recently approved by the US Food and Drug...