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Alpha Tau files first FDA PMA module for Alpha DaRT skin cancer therapy

An update from Alpha Tau Medical Ltd ( (DRTS)) is now available. On January 5, 2026, Alpha Tau Medical announced it has submitted the first module of its pre-market approval application to the U.S.
Seeking Alpha

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

- Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted - - Module submitted in parallel to ...
Yahoo Finance

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT ® ...
Yahoo Finance

CapsoVision Submits FDA 510(k) for AI-Assisted Module in CapsoCam Plus

CapsoVision, Inc. CV recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based reading feature to its CapsoCam Plus capsule endoscopy system. The ...
LGBTQ Nation

FDA threatens companies selling binders: They want to “control every ounce of trans people’s lives”

Following the announcement from the Department of Health and Human Services (HHS) of new rules that would end gender-affirming care for minors, the Food and Drug Administration (FDA) threatened ...
Monthly Prescribing Reference

FDA Adds Brain Tumor Warning to Depo-Provera Birth Control Shot

The decision comes as Pfizer faces lawsuits from more than 1000 women who say the company knew about the risks and didn’t warn them. The agency signed off last week on a label update for 2 versions of ...
Medical Xpress

FDA adds brain tumor warning to Depo-Provera birth control shot

The U.S. Food and Drug Administration (FDA) approved a new safety warning for Depo-Provera, a widely used birth control shot made by Pfizer, alerting patients to a possible risk for a type of brain ...
Self

The FDA Just Approved a Brain Tumor Warning for This Form of Birth Control

If you took the warning label that comes with your birth control and tossed it right in the trash, you wouldn’t be alone. After all, every medication comes with a risk of side effects, and those ...
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FDA issues new warning for popular birth control shot Depo-Provera

The Food and Drug Administration has approved a new warning label for Depo-Provera, one of the most widely used birth control shots in the United States. Kennedy Center board votes to rename it 'Trump ...
NBC News

FDA approves label change for Depo-Provera, adding brain tumor warning

The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.
New York Post

Marty Makary touts FDA efforts to crack down on ‘out of control’ pharmaceutical ads and end animal testing in ‘Pod Force One’ interview

President Trump’s Food and Drug Administration is cracking down on the “endless” barrage of pharmaceutical advertisements Americans are hit with on a daily basis, FDA Commissioner Marty Makary said on ...