hotspot -WSS

hotspot

author：entertainment 2025-10-03 00:40:05 - browse：2742

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： Anesthesiologist group: stop taking Ozempic before surgery
Next article： An inside look at PIPEs, biotech's buzzy new financing tool

leisure time

WSS

Search warrant issued in 1996 disappearance of Kristin Smart

Israel withdraws forces after 2

Condition critical? Britain's beloved but battered National Health Service turns 75

Myanmar's Supreme Court hears arguments in 2 appeals by ousted leader Aung San Suu Kyi

Philadelphia mass shooting: Few answers in apparently random attack as suspect charged with murder

Biden's Plan B on student loan forgiveness relies on Higher Education Act: What to know

hotspot

hotspot

hotspot

Wildfire smoke exposes gaps in outdoor worker protections

Man with guns arrested near Obama home 'attempted to evade' Secret Service: Prosecutors

As demand for Covid shots wanes, Moderna seeks its next success

AstraZeneca loses challenge to Medicare drug price negotiation

Cancer drug shortages should be causing more outrage

City of Memphis, police chief oppose effort to delay lawsuit in Tyre Nichols case

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

Biotech companies concerned about China biosecurity crackdown

Guidelines to prevent youth baseball injuries need more muscle

ALS groups 'won't be played again' by the FDA, drug sponsors

focus

Search warrant issued in 1996 disappearance of Kristin Smart

3 protesters arrested at Wimbledon after interrupting matches by throwing confetti on court

Abortion pill mifepristone to soon be dispensed at CVS, Walgreens

Myanmar's Supreme Court hears arguments in 2 appeals by ousted leader Aung San Suu Kyi

ALS groups 'won't be played again' by the FDA, drug sponsors

The leaders of Italy and Poland say European Union should focus on stopping migration

entertainment

leisure time

entertainment

explore