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UNCOVERED: 29 - Caught on Camera

The FDA's Cancer Drug Advisory Panel Has Lost Its Acting Chair and Carries Multiple Vacancies

The acting chair of the FDA's cancer drug advisory committee has departed at the end of his term, leaving ODAC with several open seats.

Medical Daily

The New Tylenol and Naproxen Pill Creates Two Different Ways to Double Up by Accident

The FDA approved the first OTC acetaminophen and naproxen combination pill. It creates two separate ways to accidentally exceed a daily limit.

Medical Daily

Judge Says the FDA Never Explained Why Mifepristone Prescriber Certification Was Necessary

A federal judge ruled the FDA failed to justify its 2023 mifepristone REMS requirements. The rules stay in effect while the agency reconsiders.

Medical Daily

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FDA Sets the Testing Standards Generic Weight Loss Injections Must Meet Before Approval

The FDA published 17 revised draft guidances setting testing expectations for generic peptide injections, including semaglutide and tirzepatide.

Medical Daily

FDA Approves a Blood Test for Colorectal Cancer Screening That Misses Most Precancerous Growths

The FDA approved SimpleScreen CRC, a blood test for colorectal cancer screening. It detects cancer well but finds few precancerous lesions.

Medical Daily

The New ADHD Drug Carries Two Boxed Warnings and Will Be a Controlled Substance

The new ADHD drug Simtriyo carries two boxed warnings, pediatric suicidality monitoring, and CNS stimulant status pending DEA scheduling.

Medical Daily

FDA Reviewers Say Melanoma Trial Data Cannot Be Verified as Advisers Weigh a Third Review

FDA reviewers say Replimune's RP1 melanoma data confound interpretation. Advisers meet July 30 ahead of an August 2 decision on a third review.

Medical Daily

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Duchenne Families Face a Three-Week Wait After FDA Advisers Rejected the Heart Therapy Evidence

FDA advisers voted 9-3 that evidence for dermaicell falls short for Duchenne cardiomyopathy. The FDA decides by August 22. What families should know.

Medical Daily

Levothyroxine: Thyroid medication recalled across US due to low potency

Major Pharmaceuticals is voluntarily recalling a number of Levothyroxine Sodium Tablets due to subpotency, the US Food and Drug Administration (FDA) has said. According to the government agency's Enforcement Report, the recall was initiated on July 13 and affects pills distributed by Major Pharmaceuticals and Cardinal Health. The recalled products…

The Independent UK

Bye-bye painful dentist visit: A simple liquid could stop tooth decay; no drilling or injections needed for many cavities

A major US clinical trial has found that silver diamine fluoride, a liquid painted onto cavities in seconds, stopped tooth decay in more than half of treated baby teeth without any drilling, injections, or sedation. Researchers say the findings could support FDA approval and transform how cavities are treated, especially…

The Economic Times

Bombay HC restores FDA-suspended Navi Mumbai hotel's licence, says 'we are in India, need a realistic approach'

The Bombay High Court quashed an FDA order suspending a hotel's food license. This action followed a surprise inspection which found only two insects. The court noted the hotel had a 95 percent hygiene compliance score. Authorities were directed to immediately restore the hotel's FSSAI license. The FDA must now…

The Economic Times

No vada pav, samosa, chocolates near schools anymore: Maharashtra bans junk food within a 50-metre radius; check list of banned items & penalties

Maharashtra FDA has banned junk food sales within fifty meters of schools. This move aims to promote healthier eating habits among students statewide. Principals and school management will face action for any violations of this new rule. Inspections will begin soon across the state to ensure strict compliance. The department…

The Economic Times

Regulators Tell Doctors to Limit Anticholinergic Drugs in Older Adults, While Saying the Dementia Question Remains Open

UK regulators reviewed 17 studies on bladder anticholinergics and dementia. The evidence could not confirm or exclude a causal link.

Medical Daily

FDA Advisers Meet Thursday on a Melanoma Therapy the Agency Says It Cannot Interpret

FDA advisers review Replimune's melanoma therapy Thursday. The agency's own briefing documents question the interpretability of the trial data.

Medical Daily

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Medical Daily

FDA Clears a Non-Invasive Test That Estimates a Heart Pressure Normally Measured with a Catheter

The FDA cleared CorVista's PCWP add-on, a non-invasive AI test estimating a heart pressure usually measured by catheter.

Medical Daily

Researchers Mapped the Protein Changes Inside Pancreatic Lesions Years Before They Turn into Cancer

A Cancer Discovery study mapped protein changes in precancerous pancreatic lesions. What it found, and what it cannot yet do.

Medical Daily

FDA Approves an At-Home Injector for the Diuretic That Usually Means a Trip to the Emergency Room

The FDA approved Furoscix ReadyFlow, an at-home furosemide autoinjector for fluid overload in heart failure and kidney disease.

Medical Daily

Four in Ten Americans Are Eating Less Produce Because of the Cyclospora Outbreak, and the Recall Never Covered Most of It

A poll found that 40% of US adults are eating less produce after the Cyclospora outbreak. Here is what the recall actually covers.

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Medical Daily

Baxter Recalls a Lot of Cefazolin, the Antibiotic Most Often Used to Prevent Surgical Infections

Baxter recalled one lot of Cefazolin in Dextrose Injection after cardboard particles were found. Why it matters for surgery patients.

Medical Daily

Lettuce Supplier Met Privately with White House Officials as Federal Cyclospora Investigation Named Its Product

Taylor Farms met privately with White House and FDA officials during the cyclospora investigation, a source told Reuters. Here is what is verified.

Medical Daily

Pancreatic Cancer Drug Doubled Survival in Phase 3 Trial. Who Qualifies for Expanded Access?

Daraxonrasib nearly doubled median survival in advanced pancreatic cancer. It is not approved yet, but expanded access is open for some patients.

The Independent UK

Signs point to a peak in explosive diarrhea cases in Michigan

The largest outbreak of cyclosporiasis is in the Great Lakes and Midwest regions, affecting nine states

Medical Daily

Toddler Fruit Pouches Sold at Kroger, Meijer and Target Recalled Over Plastic Strands Inside the Pouch

PT Organics recalled Peter Rabbit Organics Banana and Strawberry pouches sold at Kroger, Meijer and Target over soft plastic in the product.

The Independent UK

FDA approves new version of Tylenol with added ingredient

New fast-acting non-opioid drug will soon be available

Medical Daily

Lawsuits Say Taylor Farms Should Have Known: Complaints Cite a 2013 Cyclospora Outbreak and a 2024 E. Coli Death

Lawsuits over the Cyclospora outbreak allege Taylor Farms knew the risk from prior outbreaks. The company defends its protocols. No court has ruled.

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