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INSANE: 28 - The Real Truth

FDA Renamed and Updated Its Companion Diagnostics List, Including the First Test That Detects Cancer's Return in Blood

FDA updated its companion diagnostics list on July 23, adding tests that decide who gets targeted cancer drugs, including a blood-based MRD test.

Medical Daily

FDA Creates a New Device Category for Noise-Canceling Systems Inside Newborn Incubators

FDA formally classified active noise attenuation systems for infant incubators as Class II devices, setting testing and labeling requirements.

Medical Daily

Salmonella Javiana Cases Double to 212 in a Week and the FDA Still Has Not Named a Food

An FDA Salmonella Javiana outbreak doubled to 212 cases in one week. No food has been identified. Here is what that means.

Medical Daily

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FDA Advisers Back a Melanoma Treatment for Patients Who Ran Out of Options, and a Decision Is Due Monday

FDA advisers voted 10-3 to back Replimune's RP1 for advanced melanoma after two rejections. The agency's decision is due August 2.

Medical Daily

Why Is Aluminum in Deodorant Bad? What the Concern Really Means

Walk down any personal care aisle and "aluminumfree" jumps off half the boxes. The implication is clear: aluminum is something to avoid. But ask the average shopper why, and the answers range from vague cancer worries to "I just heard it's bad."

inkl

Three Medical Device Categories Established in 2023 Are Now Officially Codified by the FDA

FDA codified three device categories covering a kidney risk test, a diabetes therapy app, and at-home COVID tests. All were classified in 2023.

Medical Daily

FDA Issues an Early Alert on Boston Scientific Carotid Catheters After Reports of Tips Breaking Off

FDA issued an early alert on Boston Scientific ENROUTE carotid catheters after reports of arterial sheath tip separation during use.

Medical Daily

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Lancet Results Show Ralinepag Cut Clinical Worsening by 55 Percent in Pulmonary Arterial Hypertension

Published Lancet results show ralinepag reduced clinical worsening in PAH by 55%. The drug is still investigational and not FDA-approved.

Medical Daily

FDA Approves the First Over the Counter Tablet Combining Tylenol and Naproxen for 12 Hour Pain Relief

FDA-approved Tylenol with Naproxen, the first OTC combination of acetaminophen and naproxen sodium, for up to 12 hours of pain relief.

Medical Daily

Cardboard Found Inside a Sealed Bag of Sterile Antibiotic Prompts a Nationwide Baxter Recall

Baxter recalled many cefazolin infusion bags after cardboard was found in the sterile solution. What it means and who was exposed.

Medical Daily

FDA Approves Gwyn Lo, a Once Weekly Contraceptive Patch with a Lower Estrogen Dose

FDA-approved Gwyn Lo is a weekly contraceptive patch with lower estrogen. It is limited to women with a BMI under 30 kg/m2.

Medical Daily

Lidl Recalls Shortbread Cookies Sold in Ten Jurisdictions After Packaging Omitted Four Major Allergens in English

Lidl recalled Eridanous shortbread cookies in 9 states and DC after packaging omitted English allergen labeling for wheat, soy, milk, and egg.

Medical Daily

A Liquid Brushed on Baby Teeth Stopped Decay in More Than Half of Cavities in a U.S. Trial

A US trial of 830 children found silver diamine fluoride arrested decay in more than half of treated baby teeth without drilling.

Medical Daily

FDA Licenses the First Freeze Dried Plasma for Use in the United States

FDA licensed Ezplaz, the first freeze-dried plasma in the US, for adults needing plasma when other plasma products are not available.

Medical Daily

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Medical Daily

CDC Now Counts 6,707 Confirmed Cyclospora Cases and More Than 11,500 Others Still Under Investigation

CDC reports 6,707 lab-confirmed Cyclospora cases plus more than 11,500 under investigation as the lettuce-linked outbreak expands to nine states.

We Got This Covered

Minnesota woman accuses shopper of carrying dog covered in feces inside Target, demands to know if it’s a service animal: ‘Super sanitary’

Apparently, the dog was in the middle of the produce section.

The Independent UK

Dermatologists sound the alarm as tanning becomes trendy again

This concerning trend comes as the American Cancer Society projects over 100,000 new melanoma diagnoses in the U.S. by 2026

Marie Claire

DIY Liposuction Is Trending and Plastic Surgeons Are Not Amused

A dangerous beauty trend is gaining traction online, and the risks are... substantial.

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Medical Daily

A Psoriasis Cream Is Now Approved for Children as Young as 2, and the Data Behind It Works Differently

The FDA expanded Zoryve cream 0.3% to children as young as 2 for plaque psoriasis. What the approval rests on and what parents should ask.

Medical Daily

The FDA Is Investigating Rare Catastrophic Anesthesia Reactions Tied to a Mitochondrial Variant

The FDA is investigating rare, severe neurologic reactions to sevoflurane in patients carrying a maternally inherited mitochondrial variant.

France 24

No, there's no proof sunscreen increases cancer risk

Social media posts are pointing to a study of more than 470,000 people to argue that sunscreen increases the risk of skin cancer. However, the study didn't examine whether sunscreen is dangerous, and its findings have been largely distorted.

The Guardian - US

‘It’s a peptide wild west’: how RFK Jr is clearing way for a market of untested drugs

A century ago, compounding pharmacies helped people get bespoke drugs. Now these less-regulated businesses are fueling the peptide boom

Medical Daily

Cancer Patients Should Not Stop Treatment Over This Chemotherapy Recall, but One Question Is Worth Asking

Three lots of injectable cyclophosphamide were recalled for steel particulate. No one should stop treatment. Here is what to ask your infusion center.

Medical Daily

Active U.S. Drug Shortages Have Risen to 223, and Two Official Counts Disagree on the Scale

Pharmacists count 223 active US drug shortages while the FDA tracks far fewer. Here is why the two numbers differ and what it means for patients.

Medical Daily

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.

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