The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
Category Archives: Drug Safety Information Podcasts
FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction
The U.S. Food and Drug Administration today permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.
FDA protects kids from illegal sales of e-cigarettes, e-liquids and cigars
The U.S. Food and Drug Administration announced today it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions.
FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness
The U.S. Food and Drug Administration today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.
FDA provides $21.8 million to states for FSMA produce safety rule implementation
The U.S. Food and Drug Administration today announced the awarding of a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.
FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset.
FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset.
FDA issues final rule on safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
FDA issues final rule on safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use