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FDA
FDA approves breast cancer drug that cut progression risk by 76%
Revtorpyk was approved for women with advanced breast cancer whose disease worsened after previous hormone-based treatments; patients receiving the three-drug combination went a median 9.3 months without progression, compared with two months on standard therapy alone
Reuters
|
07.15.26
FDA approves long-used sunscreen already sold in Israel and Europe after 25-year delay
A sunscreen ingredient that has been used in Europe and Asia since 2000 and is already found in products sold in Israel has been officially approved for use in the US; It protects against UVA and UVB, is photostable and highlights US lag in sunscreen regulation
News Agencies
|
06.11.26
FDA reverses course on Moderna flu vaccine after White House meeting
A week after declining to review Moderna’s new flu vaccine, the FDA reversed course; Politico reported the shift followed a White House meeting between Trump and the agency chief, amid a broader fight over mRNA vaccines under Health Secretary Robert F. Kennedy Jr.
News Agencies
|
02.19.26
Can a pig liver save a failing human one?
As FDA-approved trials begin, researchers are testing whether a genetically engineered pig liver used outside the body can filter blood like a biological dialysis machine, giving the human liver time to rest, recover or await transplant
Tzur Gueta
|
02.10.26
FDA approves Aidoc’s first-of-its-kind AI triage platform for emergency and outpatient imaging
Powered by a single foundation model, the newly cleared solution integrates 14 acute conditions into one workflow, aiming to speed diagnoses, reduce imaging backlogs and improve patient safety in both emergency departments and ambulatory care
ynet Global
|
01.22.26
Sex after 65: FDA approves libido-boosting pill for women
US regulators expand approval of Addyi to postmenopausal women; experts say treatment for low sexual desire remains complex, with limited effectiveness and side effects
Tzur Gueta
|
12.17.25
Can Israeli medtech grow in the US without relocating? At least one firm plans to help
US-based The Mullings Group opens Israel office, aiming to accelerate Israeli medtech companies’ path to FDA clearance, commercialization and US market scale without forcing founders to relocate
Maayan Hoffman/The Media Line
|
12.17.25
FDA plans unusual warning on COVID vaccines; experts sharply criticize move
Agency considering adding a black box warning to COVID vaccines over claims of child deaths, according to CNN; critics say data are undisclosed, process lacks transparency and decision appears politically driven
ynet Global
|
12.12.25
Israeli startup QuantalX wins FDA clearance for first-of-its-kind brain function assessment system
The Delphi-MD system, combining magnetic stimulation and EEG, offers real-time, non-invasive brain health insights and sets new US regulatory standard; already in use in Israel and top US research centers, device now being deployed commercially
ynet Global
|
11.22.25
Israeli at-home ultrasound tech firm Pulsenmore soars 33% after winning FDA approval
Tel Aviv-based Pulsenmore, developer of the world’s first home ultrasound device for pregnant women, surged 33% after receiving FDA clearance to market its product, paving the way for entry into the American market
Navit Zomer
|
11.02.25
Trump administration to link covid shots to child deaths, alarming scientists
Trump officials plan to cite unverified reports tying COVID-19 vaccines to 25 child deaths at a CDC advisory meeting, alarming scientists who warn the shots are safe and protect against severe illness
Ynet Global
|
09.12.25
New eye drops approved that restore near vision without reading glasses
The FDA has approved VIZZ, once-daily eye drops that sharpen near vision for millions with age-related presbyopia; Doctors say the treatment reduces side effects seen with earlier drops and could improve quality of life
Tzur Gueta
|
08.19.25
Popular CBD products may quietly harm the liver, FDA study warns
Clinical trial finds liver damage in healthy adults taking common CBD doses, often without symptoms; researchers urge regular testing and medical oversight, especially as CBD use grows rapidly despite limited proof of benefits or long-term safety
Tzur Gueta
|
07.15.25
US approves at-home cervical cancer test; Israeli pilot programs underway
FDA’s approval of the Teal Wand, a self-sampling HPV test, marks a shift toward accessible cervical cancer screening, with Israeli HMOs piloting similar programs
Tzur Gueta
|
05.16.25
Cleaning house: Musk fires FDA employees overseeing Neuralink
Cutting comes as part of Musk's U.S. Department of Government Efficiency position aimed at improving processes under Trump's new administration
Oren Rice
|
02.18.25
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