All posts tagged: FDA

US Senate Republicans Launch Probe of Abortion Pill Makers, Escalate Pressure on FDA

US Senate Republicans Launch Probe of Abortion Pill Makers, Escalate Pressure on FDA

Published by Sam Flores

WASHINGTON, March 25 (Reuters) – U.S. Senate ⁠Republicans ⁠launched an investigation into abortion ⁠pill manufacturers on Wednesday and called on the U.S. Food ​and Drug Administration to crack down on online sales of the drug mifepristone, the ‌latest escalation in a years‑long ‌political battle over access to medication abortion. The probe is led by Republican Bill ⁠Cassidy, chairman ⁠of the Senate Health, Education, Labor and Pensions Committee. It follows ​months of criticism by conservatives that the FDA has moved too slowly in reviewing the safety protocols surrounding mifepristone, particularly after former President Joe Biden’s administration eased in‑person dispensing ​requirements and expanded telehealth access.  (Reporting by Ahmed Aboulenein in Washington; ​Editing by Matthew Lewis and Lincoln Feast.) Copyright 2026 Thomson Reuters. Source link

FDA Approves Higher-Dose Wegovy To Help People Lose More Weight

FDA Approves Higher-Dose Wegovy To Help People Lose More Weight

Published by Sam Flores

By HealthDay Staff HealthDay ReporterMONDAY, March 23, 2026 (HealthDay News) — A stronger version of the popular weight loss drug Wegovy is on the way after federal regulators signed off on a higher dose. The U.S. Food and Drug Administration (FDA) approved a 7.2-milligram dose of Novo Nordisk’s semaglutide, the active ingredient in Wegovy. Until now, the highest approved dose was 2.4 milligrams, taken as a weekly shot. The new version, called Wegovy HD, went through an accelerated review and was approved just 54 days after the application was accepted, the agency said. Novo Nordisk said the higher-dose shot is expected to be available in the U.S. in April, when the price is to be announced. The higher dose was tested in a study that tracked people for nearly 17 months. Participants who took the stronger dose lost about 19% of their body weight, or about 47 pounds on average. People taking the lower dose lost about 16% (or roughly 39 pounds). Researchers said that the higher dose may help people who don’t see enough …

FDA approves higher-dose Wegovy shots after accelerated review

FDA approves higher-dose Wegovy shots after accelerated review

Published by Daniella Wilson

Get the Well Enough newsletter with Harry Bullmore for tips on living a healthier, happier and longer life Get the Well Enough email with Harry Bullmore Get the Well Enough email with Harry Bullmore Federal regulators have approved a new, higher-dose version of the obesity drug Wegovy that may help users lose more weight and keep it off. The U.S. Food and Drug Administration approved a 7.2-milligram dose of Danish drugmaker Novo Nordisk’s semaglutide. Previously, the highest approved dose of the drug, taken as a weekly shot, was 2.4 milligrams. The new dose received accelerated review through the FDA’s ultra-fast drug review program. The approval was granted 54 days after the request for review was approved, the agency said in a statement. The new dosage will be available in April at pharmacies in the U.S., with a price to be announced then, according to the company. One doctor noted that increasing the highest dose of Wegovy from 2.4 milligrams to 7.4 milligrams is ’quite a big jump’ (Getty) European drug regulators approved the higher-dose version …

US FDA Approves GSK’s Drug for Liver Disease Related Itching

US FDA Approves GSK’s Drug for Liver Disease Related Itching

Published by Sam Flores

March ⁠19 (Reuters) – ⁠The U.S. ⁠Food and ​Drug ‌Administration approved ‌GSK’s ⁠drug for ⁠severe relentless itching ​caused ​by a type ⁠of ⁠liver ⁠disease, the company ​said on ​Thursday, ⁠making ⁠it the first treatment greenlit ⁠for the condition. (Reporting by Sriparna Roy and ⁠Christy Santhosh in Bengaluru, Bhanvi ​Satija in ​London) Copyright 2026 Thomson Reuters. Photos You Should See – March 2026 Source link

FDA approves Wellcovorin for ultra-rare disease. The Trump admin touted it as a treatment for autism

FDA approves Wellcovorin for ultra-rare disease. The Trump admin touted it as a treatment for autism

Published by Sam Flores

The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same prescription drug that the Trump administration touted from the Oval Office as a potential treatment for symptoms of autism last year. Senior administration officials announced that Wellcovorin,… Source link

FDA issues warning over clams and oysters after possible norovirus contamination

FDA issues warning over clams and oysters after possible norovirus contamination

Published by Daniella Wilson

Stay ahead of the curve with our weekly guide to the latest trends, fashion, relationships and more Stay ahead of the curve with our weekly guide to the latest trends, fashion, relationships and more Stay ahead of the curve with our weekly guide to the latest trends, fashion, relationships and more Americans across nine states are being urged to avoid eating a select number of recalled oysters and clams, which may have been contaminated with norovirus. The U.S Food and Drug Administration issued a press release Monday to tell retailers and restaurants not to serve or sell certain shellfish products thought to be contaminated. The alert has been sent to food businesses in Arizona, California, Florida, Georgia, Illinois, Nevada, New York, Oregon and Washington that have purchased recalled Manila clams. The recalled clams were harvested by the Lummi Indian Business Council and have the harvest dates between February 13 and March 3, 2026. In addition, consumers in Washington are being urged not to eat a select batch of recalled raw oysters, harvested by Drayton Harbor …

Novo Nordisk Finally Catches Bid After FDA Warns Telehealth Companies

Novo Nordisk Finally Catches Bid After FDA Warns Telehealth Companies

Published by Jenni Sidey

Novo Nordisk shares in Copenhagen finally caught a bid after the U.S. Food and Drug Administration issued 30 warning letters to telehealth companies for making false and misleading claims regarding compounded GLP-1 products (otherwise known as copycat GLP-1s) offered on their websites. FDA has warned 30 telehealth companies about misleading drug ads. Consumers should not be fooled into thinking that unapproved, compounded GLP-1 drugs—marketed by telehealth companies—are generic versions or the same as FDA-approved products. — Dr. Marty Makary (@DrMakaryFDA) March 3, 2026 Citi analyst Geoff Meacham told clients that a quick scan of some of the warning letters “shows the agency is taking issue with telehealth companies calling their compounded products’ generic Zepbound’ or ‘generic Mounjaro’ when these products are not FDA-approved.” “It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” FDA Commissioner Marty Makary wrote in a statement. Makary noted, “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not …

FDA agrees to review Moderna’s mRNA flu shot : NPR

FDA agrees to review Moderna’s mRNA flu shot : NPR

Published by Sam Flores

The Food and Drug Administration said it would review vaccine maker Moderna’s application for a new kind of flu shot after the company agreed to further study it in older people. Bill Sikes/AP hide caption toggle caption Bill Sikes/AP The Food and Drug Administration rattled the biotech industry last week when it said it wouldn’t even look at Moderna’s application to market the first mRNA flu shot. But on Wednesday, the agency reversed course and told Moderna it would review the application with some changes. FDA Commissioner Marty Makary hinted during a Pharmaceutical Research and Manufacturers of America event on Tuesday that the agency’s refuse-to-file letter to Moderna wasn’t the end for the company’s shot. “That letter, in my mind, is part of the conversation where you’ll see a dialogue between the company and the agency, and they can always, after that letter, ask for the more detailed review,” he said during the PhRMA Forum in Washington, D.C. “But that’s part of the process. That’s a conversation.” The FDA’s reversal, however, didn’t reassure health economist …

Calling the Shots: Tracking Robert F. Kennedy Jr.’s Moves on Vaccines | Healthiest Communities Health News

Calling the Shots: Tracking Robert F. Kennedy Jr.’s Moves on Vaccines | Healthiest Communities Health News

Published by Sam Flores

It was one of President Donald Trump’s more audacious picks for his Cabinet: anti-vaccine activist and alternative health advocate Robert F. Kennedy Jr. to helm the nation’s health department. Kennedy, however, won over the senators needed to confirm him to lead the Department of Health and Human Services, promising not to remove government website statements pointing out that vaccines do not cause autism and to keep current vaccine approval and safety monitoring systems intact. Ahead of being tapped by Trump for the role, he said he wouldn’t take vaccines away from those who wanted them while stressing a desire for individual choice. Since his confirmation, Kennedy has toed the line between backing vaccination as a preventive public health tool and making statements or overseeing developments that threaten to undermine that tool. His moves have played out against the backdrop of an explosion in vaccine-preventable measles cases in West Texas and an intense flu season that resulted in high rates of hospitalization, along with bird flu outbreaks that have raised the specter of another pandemic. Here’s …

“The real agenda is rejecting science”: FDA unexpectedly nixes new Moderna flu vaccine

“The real agenda is rejecting science”: FDA unexpectedly nixes new Moderna flu vaccine

Published by Sam Flores

The U.S. Food and Drug Administration is cancelling development of a new flu vaccine from biotech giant Moderna, with one unnamed senior FDA official calling the clinical trial a “brazen failure.” In a rare move, the FDA refused to consider the mRNA vaccine, which could be more effective at preventing flu infections, per a press release from Moderna. A letter signed by director of the Center for Biologics Evaluation and Research, Dr. Vinay Prasad, said the clinical trial was not “adequate and well-controlled” since it did not compare the vaccine to “the best-available standard of care in the United States at the time of the study.” The issue came down to the study design: control group participants over 65 did not receive the high-dose flu shot; instead, they received a regular flu shot. Moderna CEO Stéphane Bancel said the FDA approved both the study design and the vaccines used. “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study …