FDA News & Updates

Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations
Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies
Daurismo New Treatment Approved for Older Adults with Acute Myeloid Leukemia
Xospata First Therapy Approved for Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation
Truxima First Biosimilar to Rituxan FDA-Approved for Non-Hodgkin Lymphoma Read More ›

Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas
Venclexta Approved in Combination for Older Adults with Acute Myeloid Leukemia Read More ›

Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. Read More ›

In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD. Read More ›

In 2017, the US Food and Drug Administration (FDA) approved 46 new drugs, a 21-year high. In addition to these impressive approvals, the first-ever 3 gene therapies were also approved. FDA Commissioner Scott Gottlieb, MD, noted that these approvals represent “a whole new scientific paradigm for the treatment of serious diseases.” Read More ›