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FDA approves breakthrough drug for metastatic pancreatic cancer: 'A real revolution'

After decades of efforts to block the tumor-driving RAS protein, the FDA approved daraxonrasib after unprecedented survival gains in metastatic pancreatic cancer; treatment costs about NIS 90,000 a month, raising access concerns

Eitan Gefen | 08.27.26

The new blood test is designed to help diagnose Alzheimer’s in people age 40 and older with cognitive symptoms

For the first time, new blood test can help detect Alzheimer’s from age 40

A new FDA-approved blood test could help detect Alzheimer’s from age 40 by measuring proteins linked to brain amyloid; intended for people with cognitive decline, it showed high predictive accuracy and is due in the US later this year

Tzur Gueta | 08.24.26

Symptoms improved within first week: FDA approves new ADHD drug for children, adults

Simtriyo, the first approved ADHD drug to inhibit norepinephrine, dopamine and serotonin reuptake, improved symptoms within a week; US launch depends on controlled-substance classification, and it is not yet available in Israel

Tzur Gueta | 08.02.26

FDA approves first cholesterol pill to match powerful injectable drugs

Merck’s once-daily Lipfendra offers a pill alternative to injectable cholesterol drugs after Phase 3 trials involving Israeli patients

Daniel Edelson, New York | 07.17.26

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

טראמפ במסיבת העיתונאים על התקיפה בונצואלה

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

Aidoc founders Michael Braginsky (left), Elad Walach and Guy Reiner

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

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AI AI agents Amazon Prime Antisemitism Apple TV+Arab Israelis Artificial Intelligence assassination attempt Band Benjamin Netanyahu