FDA approves new treatment for certain digestive tract cancers
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The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
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The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation.
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
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The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
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The U.S. Food and Drug Administration today approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.
FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care
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Today the U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug.
FDA launches public education campaign to encourage adult smokers trying to quit cigarettes
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Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. These messages will be displayed in and around gas stations and convenience stores - retail locations where smokers face a multitude of triggers and that typically feature cigarette advertisements.
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
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The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.
More Pharma News ...
- EMA to relocate to Amsterdam, the Netherlands
- FDA approves pill with sensor that digitally tracks if patients have ingested their medication
- FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
- FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
- FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
- FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
- FDA awards six grants for natural history studies in rare diseases