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FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.

In light of the possibility of continued ethylene oxide sterilization facility closures, FDA is again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.

The FDA is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos.

FDA statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

Today, the FDA is taking two new steps toward clarifying the agency’s approach on homeopathic products.

FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene, estimated to represent 90% of the cystic fibrosis population.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

The FDA announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.

Today, FDA allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test FDA has allowed to be marketed in the U.S. for Ebola Virus Disease (EVD).

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses

FDA approved Descovy in at-risk adults and adolescents for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

FDA awards two grants for natural history studies in rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by a remote attacker—may introduce risks for medical devices and hospital networks