explore -WSS

explore

author：explore 2025-09-30 23:06:41 - browse：241

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： Hollywood unions extend contract negotiations for actors
Next article： What Henrietta Lacks settlement says about racism in medicine

hotspot

WSS

Nearly two

Nearly two

Medicare solvency divides Republicans at the presidential debate

Biotech incubator Curie.Bio graduates its first startup

ProMED, early warning system on disease outbreaks, in peril

What Mike Pence has said that could be used in a Donald Trump trial

hotspot

explore

hotspot

New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

Diversify hospital leadership teams to protect BIPOC patient health

United colonoscopy coverage change 'may cost lives,' doctors say

STAT Executive Editor Rick Berke on STAT's 8th birthday

Hepatitis C has a cure — but many Americans still lack access to it

2 US Navy sailors arrested for allegedly spying for China

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

STAT Executive Editor Rick Berke on STAT's 8th birthday

The high cost of giving birth even with insurance

Trump drops motion seeking removal of DA probing efforts to overturn 2020 election in Georgia

knowledge

Excited delirium, Elijah McClain, and emergency physicians

Gilgo Beach: Police identify another victim in serial killing investigation

Nearly two

Medicare solvency divides Republicans at the presidential debate

10 million people disenrolled from Medicaid over past six months

Treeline, Josh Bilenker's next biotech, is cloaked in mystery

entertainment

hotspot

leisure time

hotspot