FDA Approvals

The US FDA has granted approval to an adjuvant therapy for HER2-positive breast cancer at high risk of recurrence.
The US Food and Drug Administration approved an adjuvant treatment for patients with completely resected melanoma.
A new drug developed by Merck & Co and Pfizer Inc won U.S. approval on Wednesday to treat type II diabetes, the Food and Drug Administration said, adding another competitor to a growing class of treatments.
Cancer treatments from Pfizer Inc and Exelixis Inc on Tuesday won approval from the US Food and Drug Administration for expanded use in previously untreated patients.
The US Food and Drug Administration has approved a biosimilar to infliximab for the treatment of rheumatoid arthritis.
The FDA has given full approval to a drug for the treatment of adults with a recurrent type of brain cancer that has progressed following prior therapy.
The US Food and Drug Administration has approved a next-generation sequencing assay that may be used as a companion diagnostic for therapy selection for solid tumors.
The US FDA has granted approval to a biosimilar for trastuzumab (Herceptin) for the treatment of HER2-positive breast cancer and metastatic stomach cancer.
The US FDA has granted approval to the first breakthrough-designated, next generation sequencing-based test that detects mutations in 324 genes in any solid tumor type.
The FDA has approved an adjuvant treatment for adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.