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FDA Approvals, News & Updates

The US Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
The US Food and Drug Administration (FDA) has approved etanercept-szzs, a biosimilar to etanercept (Enbrel), for the treatment of multiple inflammatory diseases, according to an announcement by the organization. The biosimilar injection has been approved to treat patients with moderate-to-severe rheumatoid arthritis; moderate-to-severe polyarticular juvenile idiopathic arthritis; active psoriatic arthritis; active ankylosing spondylitis; and chronic, moderate-to-severe plaque psoriasis.
  • Zinbryta a New Treatment Available for Relapsing Multiple Sclerosis
  • Nuplazid First Drug Approved for Hallucinations and Delusions Associated with Parkinson's Disease
  • Fluciclovine F18 Diagnostic Imaging Agent Approved to Detect Recurrent Prostate Cancer
  • Tecentriq for Metastatic Urothelial Bladder Cancer
  • Afatinib Receives New Indication for Advanced Squamous-Cell NSCLC
  • FDA Approves Netspot Diagnostic Test to Detect Neuroendocrine Tumors
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
  • Cabometyx Receives FDA Approval for Advanced Renal-Cell Carcinoma
  • Venclexta First BCL-2 Targeted Drug Approved for Patients with CLL plus 17p Deletion
  • First Blood Test for CRC Screening Approved by FDA
  • Defitelio FDA Approved for Hepatic Veno-Occlusive Disease After HSCT
  • FDA Approves Infliximab Biosimilar for Multiple Indications
  • Ixekizumab FDA Approved for Patients with Plaque Psoriasis
  • First Once-Daily, Oral JAK Inhibitor Approved for Patients with RA
  • Xalkori Receives New Indication for Metastatic Non–Small-Cell Lung Cancer with the ROS-1 Mutation
  • Afinitor Granted New Indication for Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors
  • FDA Designates Iomab-B as Orphan Drug in the Treatment of Relapsed and/or Refractory Acute Myeloid Leukemia in Older Patients
The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
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