In a major step forward for women’s health, the U.S. Food and Drug Administration has approved the Teal Wand — the first at-home device for cervical cancer screening. This breakthrough means women may soon be able to skip the speculum and stirrups and screen for cervical cancer from the comfort of their own home.

A Game-Changer for Cervical Cancer Screening

Developed by Teal Health, the Teal Wand allows users to collect their own vaginal samples at home and send them to a lab for HPV testing. The device will be included in Teal Health’s upcoming at-home screening kit, which will be available by prescription starting this June — launching first in California, with plans to expand across the U.S.

“This is the same test, with the same accuracy as in-clinic collection — but now you can do it from home,” said Teal Health CEO Kara Egan. “It gives women more options, especially through telehealth, and increases access to essential care.”

How It Works

Here’s how the process unfolds:

1. Request a Kit: Patients begin by visiting Teal Health’s website to request a kit.
2. Telehealth Visit: A quick consultation with a provider results in a prescription.
3. At-Home Collection: The patient uses the Teal Wand to collect a sample in private.
4. Mail to Lab: The sample is sent to a lab and analyzed using Roche’s HPV testing platform.
5. Results & Follow-Up: Results are reviewed by a clinician and shared with the patient. If needed, follow-up care is arranged.

Why It Matters

HPV (human papillomavirus) is the leading cause of cervical cancer, and early detection is critical. Yet millions of people in the U.S. are not up to date on their screenings. According to the CDC, about one in four adults fall behind on cervical cancer screening guidelines.

“This new test could be a game-changer,” said Dr. Ami Vaidya, co-chief of gynecologic oncology at Hackensack University Medical Center. “Some women avoid Pap smears due to discomfort or fear. Giving them a reliable at-home option could increase regular screenings, especially for those without easy access to a doctor.”

Support from Experts

The American Cancer Society praised the FDA’s decision.
“Most cervical cancers are found in people who were never screened or haven’t been screened recently,” said Dr. William Dahut, the organization’s chief scientific officer. “This at-home test adds a powerful tool in our fight against a potentially deadly disease.”

Understanding Cervical Cancer Screening

Cervical cancer screening typically involves:

• Pap tests (cytology): Detects abnormal cell changes in the cervix.
• HPV testing: Checks for the virus that can cause those changes.

The U.S. Preventive Services Task Force recommends:

• Women ages 21–29: Pap test every 3 years.
• Women ages 30–65: Either Pap test every 3 years, HPV test every 5 years, or both tests every 5 years.

Teal Health’s self-collection kit is designed to match the accuracy of these traditional methods while removing barriers like scheduling appointments or facing uncomfortable procedures.

What’s Next?

Teal Health is currently in talks with insurance providers to cover the cost of the kit. For those without insurance, pricing will be announced soon. A waitlist is already open on the company’s website.

With FDA approval now in place, the future of cervical cancer screening is looking more accessible — and more comfortable — than ever.

Source: CNN – FDA approves first cervical cancer screening device that can be used at home, company says

The post FDA Approves First At-Home Test for Cervical Cancer Screening appeared first on Journos News - Breaking News, World News, Top Stories, Todays Headlines and Flash Reports.

The FDA announced Thursday that specialty pharmacies and online companies selling off-brand copies of two popular drugs for obesity and diabetes must phase out their versions by next year.

This decision comes after the Food and Drug Administration confirmed that the nationwide shortage of Eli Lilly’s blockbuster drugs, Zepbound and Mounjaro, has been resolved. The resolution eliminates the need for knockoff versions, which had become increasingly popular among Americans seeking weight loss solutions.

Lilly, which has been urging the FDA to take action for months, scored a victory with this ruling. The decision will likely change how patients access these medications and could affect the cost of treatment.

Resolving Shortages and Impact on Patients

Zepbound, approved for obesity treatment, and Mounjaro, approved for diabetes, both contain the active ingredient tirzepatide. The FDA confirmed Thursday that Lilly’s production of these drugs is now meeting or surpassing demand, effectively resolving a shortage that had lasted for over two years.

Both drugs belong to the GLP-1 class, known for their exceptional weight loss results by reducing appetite and increasing feelings of fullness. While Zepbound and Mounjaro are now in steady supply, competing GLP-1 drugs like Wegovy and Ozempic, from Novo Nordisk, are still facing shortages.

The explosive demand for GLP-1 drugs has led to the rise of compounding pharmacies and telehealth companies like Hims and Ro, which began offering cheaper alternatives. These knockoffs were typically sold online for several hundred dollars per month.

Phasing Out Knockoff Versions

Under the FDA’s new decision, businesses have between 60 and 90 days, depending on their size, to stop selling these off-brand products. The FDA allows compounded versions of brand-name drugs when there is a shortage, but with the supply of Lilly’s drugs now stable, the shift back to authorized medications is expected to improve consumer safety.

The FDA had warned patients last year about issues with the ingredients and formulations of some GLP-1 drugs sold online. Since compounding pharmacies are mainly overseen by state authorities, the FDA’s oversight in this area has been limited. Compounding pharmacies create customized medications by using raw drug ingredients, often for patients with specific allergies or needs. The growing industry has expanded into a multibillion-dollar business, especially amid increasing drug shortages.

The Role of Telehealth Companies

Telehealth companies, which have been aggressively marketing off-brand GLP-1 drugs, are also contributing to the growing demand. These companies operate outside the same marketing regulations as traditional drugmakers, which has led to increased concerns about the safety and quality of the products being sold.

Earlier in October, the FDA had declared an end to the Mounjaro and Zepbound shortage, but faced public backlash and a lawsuit from compounding pharmacies, prompting the agency to reverse its decision.

The new ruling from the FDA ensures that patients will now be able to access drugs that are both safe and properly regulated, marking a significant shift in how these popular treatments will be distributed moving forward.

Source

The post Lilly’s Obesity Drugs: FDA Ends Shortage, Phases Out Off-Brand Versions appeared first on Journos News - Breaking News, World News, Top Stories, Todays Headlines and Flash Reports.