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Fda

All articles tagged with #fda

health-and-fitness13 hours ago•2 min saved

Doctors Urge Expanded Awareness of Hormone Replacement Therapy for Women

Doctors say estrogen replacement can benefit many women by addressing hormonal fluctuations that affect the menstrual cycle, heart, bones, and brain; despite past fears from the Women’s Health Initiative and FDA warnings, updated research and guidance are expanding who should consider HRT, with estrogen levels that can require multiple tests to monitor; it's never too late to start for postmenopausal or younger patients experiencing imbalance.

via ABC7 Los Angeles|

#estrogen #fda #health-and-fitness

biotechnology23 hours ago•2 min saved

FDA Rejects Replimune’s Engineered Virus for Melanoma Again, Sparking Regulatory Debate

The FDA has once more rejected Replimune’s engineered virus therapy for advanced melanoma, a decision that underscores the ongoing debate over tightening agency standards amid leadership changes; the treatment is designed to boost the immune system’s attack on skin cancer, but regulators say the data remain insufficient.

via statnews.com|

#biotechnology #fda #melanoma

health1 day ago•257 min saved

FDA clears Waters' at-home HPV screening to speed cervical cancer detection

The U.S. FDA has cleared Waters’ at-home cervical cancer screening kit for use with an approved HPV test, enabling patients to self-collect samples at home and mail them to a laboratory. The kit, tested with BD’s Onclarity HPV assay, targets high-risk HPV types and aims to improve early detection and reduce cervical cancer deaths, with Waters planning nationwide availability by prescription and anticipated insurance coverage.

via AOL.com|

#cervical-cancer #fda #health

policy12 days ago•5 min saved

Regulatory rethink: FDA weighs adding peptides and non-food ingredients to supplements

Industry groups are pressing the FDA to broaden dietary-supplement rules beyond food-derived ingredients to include substances like peptides and probiotics, prompting a public meeting on how a 1994 framework could accommodate non-traditional ingredients while grappling with safety, oversight, and the balance between innovation and consumer protection.

via PBS|

#dietary-supplements #fda #peptides

health14 days ago•4 min saved

Peptides on the Internet: Hype, Hazards, and the Evidence Gap

Online peptide products are marketed as cures and anti-aging solutions, but most are unregulated and lack solid human trials; safety and efficacy are not guaranteed. FDA-approved peptide uses exist (e.g., insulin, skincare components, GLP-1 medications), yet the unregulated market operates like a “wild west” with red flags. Social media and e-commerce drive interest, while experts warn that real, rigorous evidence is often missing and claims should be viewed skeptically.

via CBS News|

#fda #health #health-claims

health18 days ago•7 min saved

Calorie labels are estimates, not exact numbers, nutrition scientists say

Calorie counts on packaged-food labels are estimates with a typical tolerance of up to 20% due to variations in digestion, absorption, and fiber; bomb calorimetry is the most accurate method but many labels rely on Atwater factors, which approximate calories from fat, carbs and protein. Restaurant and processing differences add to the uncertainty, and insoluble fiber can make actual absorbed calories lower than listed. The takeaway is to treat label numbers as rough guides and compare similar products rather than fixating on precise calories.

via NBC News|

#atwater-factor #bomb-calorimeter #calories

health-policy19 days ago•12 min saved

Kennedy eyes FDA action to widen peptide access and spur a booming market

Health Secretary Kennedy Jr. signals that the FDA will broaden access to peptide therapies—a fast-growing, largely unregulated market—by taking action that could loosen rules for domestic compounding. Supporters say it will improve patient access, while critics warn of safety risks due to limited long-term data and a thriving gray/black market for unproven products. The move comes amid industry litigation, lobbying by compounding pharmacies, and high commercial interest in peptide-based treatments like GLP-1 therapies.

via Politico|

#compounding-pharmacies #fda #health-policy

health-public-health21 days ago•2 min saved

FDA Pauses Minor Tanning-Bed Restrictions to Reassess Rulemaking

The FDA has withdrawn its 2015 proposal to restrict tanning bed sales and use by minors after more than 8,000 public comments, indicating it will study alternatives and potential unintended consequences before possibly restarting rulemaking. The move drew pushback from dermatology groups emphasizing the melanoma risk associated with UV exposure in youth, while noting prior steps in 2014 requiring warning labels and premarket review for sunlamp products.

via MedPage Today|

#fda #health-public-health #melanoma-risk

health21 days ago•3 min saved

FDA Drops Plan for Nationwide Minor Tanning-Bed Ban, Shifts Regulation to States

The FDA has withdrawn a proposed rule that would have banned tanning bed use for anyone under 18 and required parental waivers for adults, leaving regulation up to states; UV exposure from sunlamps raises skin-cancer and melanoma risk, and devices can emit up to 15 times more UV than sunlight. Warnings remain on devices, but experts debate whether warnings alone are enough without a federal ban while the agency pursues other sunlamp regulations in the future.

via U.S. News & World Report|

#fda #health #melanoma

health21 days ago•2 min saved

Huge recall: nearly 90,000 bottles of children's ibuprofen pulled over foreign material

The FDA announced a recall of about 89,592 bottles of Strides Pharma’s Children’s Ibuprofen Oral Suspension sold in the U.S. after reports of a gel-like mass and black particles. The Class II recall affects lot numbers 7261973A and 7261974A with an expiration date of Jan. 31, 2027, manufactured for Taro Pharmaceuticals USA Inc. and distributed nationwide. No serious adverse health effects have been reported, but consumers should stop using the recalled product immediately.

via WCNC|

#children #fda #health

health21 days ago•12 min saved

FDA recalls Taro’s kids’ ibuprofen amid safety notice

The FDA has issued a recall for a children’s ibuprofen product from Taro Pharmaceuticals, urging consumers to check for affected lots and stop use if they have the product, with guidance on refunds or replacements.

via AP News|

#children #fda #health

health22 days ago•3 min saved

FDA Clears Higher-Dose Wegovy to Boost Weight Loss

The FDA approved Wegovy HD, a 7.2 mg weekly dose of semaglutide, a higher-dose version expected to boost weight loss. In trials, the higher dose yielded about 19% body-weight loss (roughly 47 lb) vs 16% (about 39 lb) with the 2.4 mg dose over about 17 months; the drug will be available in April with price to be announced. European regulators had approved it earlier. Side effects were common (GI issues in 70%+; 23% reported skin sensations) and serious adverse events occurred in ~7% of the higher-dose group. The jump from 2.4 mg to 7.2 mg is substantial, and real-world safety will need monitoring. An oral Wegovy pill was approved by the FDA in December for context.

via ScienceAlert|

#fda #health #obesity-drug

health22 days ago•2 min saved

FDA approves Wegovy HD, a higher-dose weight-loss option under a national priority program

The FDA cleared Wegovy HD (7.2 mg) for weight loss and long-term maintenance in adults with obesity or overweight plus a weight-related condition, marking the fourth approval under the Commissioner’s National Priority Voucher program. The higher dose yielded greater average weight loss with a safety profile consistent with prior semaglutide doses, though GI side effects were common and there is a boxed warning for thyroid C-cell tumors; the approval was granted to Novo Nordisk, and a June public hearing on the voucher program is planned.

via fda.gov|

#fda #health #national-priority-voucher

health22 days ago•5 min saved

FDA shelves federal teen-tanning rule, deferring to state laws

The FDA withdrew its 2015 proposed rule that would have barred anyone under 18 from using tanning beds, leaving regulations to state laws that already restrict or permit teen use. The withdrawal followed more than 8,100 public comments, with concerns about compliance burdens and personal choice, while authorities emphasize that UV exposure raises skin cancer risk and that sunlamps still warrant caution and potential future regulatory action.

via NBC News|

#fda #health #minors

health22 days ago•14 min saved

FDA clears higher-dose Wegovy injections for obesity treatment

The FDA has approved a higher-dose Wegovy (semaglutide) injectable for obesity treatment, expanding weekly dosing options to help with weight management amid ongoing efforts to address obesity-related health risks.

via AP News|

#fda #health #obesity