FDA OKs Once-Nightly Lumryz for Children With Narcolepsy
The US Food and Drug Administration (FDA) has approved Avadel Pharmaceuticals’ supplemental new drug application for extended-release sodium oxybate (Lumryz)...
FDA
Hummus sold in Oregon and Washington recalled because of plastic in product
Pacific Coast Fresh CO of Portland, OR, is recalling King Harvest Spinach Hummus because of the potential for plastic fragments...
Gorilla Mind dietary supplement recalled because of Salmonella contamination
Gorilla Mind LLC of Boise, ID, is recalling Rauwolscine Dietary Supplement because of potential Salmonella contamination. According to the details...
New stents for infants mean kids could avoid series of open heart operations
The FDA recently approved a heart stent made specifically for infants and young children, a device that could help kids...
Coca-Cola recalls thousands of cases of mislabeled ‘zero sugar’ lemonade for containing sugar
Thousands of cases of improperly labeled Minute Maid Zero Sugar Lemonade have been recalled after they were found to contain...
Intermountain Medical Center First in Nation to Use FDA-Approved Device to Treat Aortic Aneurysms
Intermountain Medical Center First in Nation to Use FDA-Approved Device to Treat Life-Threatening Aortic Aneurysms, Providing New Hope for Patients...
Compounding pharmacies can resume making tirzepatide as FDA reconsiders shortage
The FDA said in a court filing late Friday that it would allow pharmacists to continue making compounded versions of...
Nationwide Mushroom Recall Over Bacterial Contamination Fears
While the infection is usually mild, more serious infections were described by the FDA as "serious and sometimes fatal."Read More
FDA cracks down on food importers for major safety violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some...
FDA steps up import enforcement because of pesticides, heavy metals and more
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries....
Marstacimab Gets FDA Nod for Hemophilia A or B Without Inhibitors
MedPage Today) -- The FDA approved marstacimab (Hympavzi) for routine prophylaxis to prevent or reduce bleeding episodes in adults and...
AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF
The� International Medical Device Regulators Forum (IMDRF) �consists of medical device regulators from around the world that voluntarily convene to...
FDA approves new treatment for hemophilia A or B
Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of...
Study Evaluates Safety of BPO Products for Acne
Among 111 prescription or over-the-counter products for acne that contain benzoyl peroxide (BPO), 38 (34%) contained benzene levels above the...
Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad
Compounding pharmacies could make knockoffs during shortage. But FDA says it's over...Read More
FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome
MedPage Today) -- Ahead of an FDA advisory committee meeting on Thursday, agency reviewers cast doubt on the efficacy of...
FDA chief will wrap up the first month of new human foods program with Alliance webinar
One month into the FDA’s new Human Foods Program, Deputy Commissioner Jim Jones will appear in a webinar by the...
FDA Says Over 5.4 Million Eggs May “Cause Serious Adverse Health Consequences or Death”
FDA Says Over 5.4 Million Eggs May "Cause Serious Adverse Health Consequences or Death”Read More
FDA Expands Milo’s Poultry Farms Egg Recall Due to Salmonella Outbreak
Milo's Poultry Farms has expanded its egg recall and the FDA investigation of salmonella infections is ongoing. The post FDA...
FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities
The U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test,...
