explore -WSS

explore

author：comprehensive 2025-09-06 04:13:08 - browse：8

Amid the stunning rebuke Amgen suffered at the hands of the U.S. Food and Drug Administration this week lurk numerous questions. And one of them may be whether the company was fully forthcoming about a pricey lung cancer drug that is supposed to generate key revenue growth.

At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021. This process, known as accelerated approval, required the company to run a confirmatory study. But ahead of an advisory panel meeting on Thursday, the agency released documents showing its staff found “potential systemic bias” in the trial.

The disclosure throws into question the future of this drug, which has offered hope to patients for whom an effective treatment previously seemed out of reach. Some Wall Street analysts are now betting the FDA will ask Amgen to run yet another trial or maybe withdraw the drug altogether. Either way, the prognosticators are reworking their calculus for Amgen stock.

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

Subscribe Log In

Previous article： Walensky prepares to leave CDC — and Congress — behind
Next article： Congress needs to close a vaccine

WSS

ASCO Daily Recap: CAR

N.Y. state detects polio case, first in the U.S. since 2013

An outdated Medicare rule harms dementia patients with anxiety

Novartis is flashing warning signs about its newly acquired myelofibrosis drug

Data don't support strong claims for Covid

New research casts further doubt on a common procedure used with IVF

focus

explore

focus

Alkermes shareholders re

ASCO Takeaways: Winners, snoozers, and the art of cancer care

DIEP, the 'gold standard' of breast reconstruction, is under threat

Anthony Fauci pushes back on GOP claims during Covid hearing

Drug repurposing or repositioning? The language matters

Insurance companies sue energy corporation after it was blamed for helping start Colorado wildfire

Heart attack and stroke risk calculators need revising

For pregnant people, addiction treatment shouldn't mean a call to child protective services

Jerome Adams on the need for new antivirals for Covid

California’s proposed $25 per hour health care minimum wage

hotspot

'Little Tech' descents on D.C., wanting a say in how AI is regulated

DOJ reversal could clear way for Carroll's 1st lawsuit against Trump to proceed

A new study sees potential in DNA sequencing of infants

Congress needs to close a vaccine

California’s proposed $25 per hour health care minimum wage

Oak trusses raised to roof of fire

Wikipedia

focus

hotspot

entertainment