August 22, 2024 by Ernie Mundell Updated shots you may soon get to shield against COVID-19 infection were approved by the U.S. Food and Drug Administration on Thursday. This year’s approval for the updated mRNA vaccines comes much sooner than happened in 2023, when fall vaccines were authorized on Sept. 11. The latest shots from...
Tag: <span>FDA</span>
The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use
August 20, 2024 by David Hilzenrath, Kaiser Health News Credit: Unsplash/CC0 Public DomainIn 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device—”a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” an FDA notice about the recall said. But neither...
FDA warns of danger from at-home chemical peels
August 1, 2024 by Ernie Mundell Don’t use a chemical peel to help rejuvenate your skin unless it’s done under the supervision of a trained professional, the U.S. Food and Drug Administration has advised. “FDA is warning consumers not to purchase or use certain chemical peel skin products without appropriate professional supervision due to risk...
FDA warns of accidental overdoses from compounded versions of Ozempic
July 30, 2024 by Dennis Thompson Pixabay/CC0 Public DomainPeople taking compounded versions of Ozempic have been overdosing on the drug, the U.S. Food and Drug Administration warns. These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA added. “Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug...
FDA Approves New Treatment for Primary Axillary Hyperhidrosis
Medscape Medical News > FDA Approvals Doug Brunk June 25, 2024 The Food and Drug Administration has approved a topical anticholinergic, sofpironium topical gel, 12.45%, for the treatment of primary axillary hyperhidrosis in adults and children aged ≥ 9 years. According to a press release from Botanix Pharmaceuticals, which developed the product and will market...
FDA adds Fasenra indication for severe asthma in children
by Lori Solomon The U.S. Food and Drug Administration has approved an additional indication for AstraZeneca’s Fasenra (benralizumab) as an add-on maintenance treatment for patients aged 6 to 11 years with severe asthma and an eosinophilic phenotype. This indication was supported by evidence from the Phase III TATE trial, as well as data from additional...
No End in Sight for National ADHD Drug Shortage
Alicia Ault Nearly 18 months after the US Food and Drug Administration (FDA) first acknowledged a national shortage of Adderall, the most common drug used to treat attention-deficit/hyperactivity disorder (ADHD), there is now a widespread scarcity of other stimulant medications — with no end in sight. How did this crisis develop and what measures are...
Seniors, FDA has 5 medication tips to keep you safe
by Dennis Thompson When settling into your senior years, you need to be especially careful when taking medicines, herbal remedies and supplements, the U.S. Food and Drug Administration says. That’s because older adults are likely to use more prescription and over-the-counter medications, which increases the risk of harmful side effects and drug interactions, the FDA...
FDA expands use of asthma med Xolair to treat food allergies
by Ernie Mundell People threatened by accidental exposure to foods they’re allergic to may have a new weapon of defense: On Feb. 16, the U.S. Food and Drug Administration expanded the use of the asthma drug Xolair to help prevent anaphylactic reactions. Xolair (omalizumab) is an injected drug and is not meant as a substitute...
FDA OKs Neuroimaging Tool to Aid Diagnosis of Degenerative Brain Diseases
The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases. Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson’s disease (PD). A recent meta-analysis of 12 neuromelanin MRI studies...