The FDA has given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy status. This classification suggests the treatment has demonstrated significant potential in early clinical evidence, allowing the FDA to assist and expedite subsequent development and review processes.
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Twenty years after the breakthrough discovery illustrating how RNA interference can be used to silence certain genes, and over a decade after the research won a Nobel prize, the U.S. Food and Drug Administration has approved the first drug utilizing this method for adult clinical treatment.
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The U.S. Food and Drug Administration (FDA) has granted priority review to a new antiviral drug that has been shown to notably reduce the duration of influenza symptoms. This single-dose drug is fast-acting and will potentially be approved for use in the United States by the end of 2018.
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After successful and safe clinical trials, the FDA has approved a first-of-its-kind migraine preventative medicine. It's the first in an entirely new class of drugs designed to block the activity of a specific peptide known to activate migraines that has been cleared for public use by the agency.
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The FDA has authorized, for the first time, a direct-to-consumer (DTC) genetic test to report on three genetic variants found on BRCA1 and BRCA2 genes. These genetic variants are known to increase a person’s risk for developing primarily breast cancer, but also also ovarian or prostate cancers.
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The first diagnostic blood test to evaluate the severity of a concussion has been approved for marketing by the FDA. The blood test can accurately identify patients with brain tissue damage, or intracranial lesions, following a head injury without the need for an expensive & time-consuming CT scan.
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It's been a truly historic year for modern medicine with the FDA for the first time approving several gene therapies for public use. The latest approval, this time for treating a rare form of inherited vision loss, marks 2017 as a milestone year in the field of medicine.
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Following on from authorities in the European Union, United Kingdom and Australia cracking down on homeopathic treatments, the FDA is proposing a new “risk-based enforcement approach” promising greater scrutiny into the massive US$3-billion-dollar industry.
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The FDA has just approved a new form of gene therapy for treating young patients with a type of blood and bone marrow cancer. This is the first gene therapy of its kind to be approved for use in the US, but it has the potential for severe side effects as well as a prohibitive price tag.
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US Marshals recently seized five vials of a smallpox vaccine from a stem cell treatment center in California. The action was undertaken on behalf of the FDA, which followed up the seizure with a larger announcement targeting the “unscrupulous clinics” selling unproven stem cell treatments.
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