FDA Updates

• FDA Resumes Operations After Government Shutdown Ends
• FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
• FDA Approves Pembrolizumab for Merkel-Cell Carcinoma

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 ›

The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test. Read More ›

The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib. Read More ›

On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults. Read More ›

On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis) for the treatment of patients with advanced renal-cell carcinoma (RCC) who had received anti-angiogenic therapy.  Read More ›

Read More ›

On October 18, 2016, atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, was approved by the FDA for patients with metastatic non–small-cell lung cancer (NSCLC) associated with the EGFR or ALK genetic mutations whose disease progressed during or after treatment with platinum-containing chemotherapy. Read More ›

The US Food and Drug Administration has granted accelerated approval to pembrolizumab (Keytruda injection) for use in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-containing chemotherapy. The injection is recommended to be administered at 200 mg intravenously for 30 minutes every 3 weeks. Read More ›

Daclizumab (Zinbryta) has been approved by the US Food and Drug Administration for adults with relapsing forms of multiple sclerosis. The drug is self-administered by the patient monthly, and comes in the form of a long-acting injection. Read More ›