focus -WSS

focus

author：comprehensive 2025-09-02 11:49:00 - browse：7

The FDA building -- First Opinion coverage from STAT — Adobe

The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground following a Food and Drug Administration advisory committee meeting Thursday.

Regulatory advisers voted 10-2 that the data on the company’s drug Lumakras, a treatment for lung cancer, could not be properly assessed. Lumakras targets a specific mutation to a protein called KRAS, which is one of the most common genetic mutations in cancer.

The vote comes as Amgen is hoping to convert a conditional approval for the drug to a full approval based on a 345-person study called CodeBreaK 200, in which Lumakras met the primary endpoint, delaying tumor growth approximately five weeks longer than the standard of care medication, docetaxel. The drug didn’t extend patients’ overall survival.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Medicare details structure of new drug price negotiation program
Next article： Indian pharmaceutical industry in denial over drug

hotspot

Wikipedia

WSS

Hospitals struggle to profit from CAR

Elevance, private equity launch primary care company

What nurses really want: sufficient staffing for patient care

Tocagen's brain cancer gene therapy trial continues. Investors worry

Bird flu outbreak in cows is latest avian flu curveball

H5N1 bird flu: what we're starting to learn about infection in cows

focus

focus

entertainment

Walensky prepares to leave CDC — and Congress — behind

Software glitch causes Tandem insulin pump to shutdown, FDA warns

Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

Wildfires rage amid heat wave in Greece, prompting evacuations and call for European support

Drug repurposing or repositioning? The language matters

A Q&A with Gavi’s Seth Berkley on vaccines, Covid, and more

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

Ending racial health disparities hinges on penalties, political will

George Santos makes 1st court appearance after pleading not guilty to 13 counts

Driven by the pandemic, applicants flood public health schools

entertainment

Senate committee advances SCOTUS ethics bill after alleged justice misconduct

I learned firsthand about improving diversity in clinical trials

Elevance, private equity launch primary care company

Use wet bulb globe temperature, not heat index, to protect workers

Readout Newsletter: Sanofi, Novavax, Maze x Shionogi news

Stanford president's case begs question: Who takes blame?

hotspot

hotspot

Wikipedia

hotspot