explore -WSS

explore

author：comprehensive 2025-09-30 22:05:08 - browse：358

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： Apple is now the first public company to be valued at $3 trillion
Next article： Generate Biomedicines machine learning biotech raises $273M

Wikipedia

WSS

How to make the FDA’s new prescription one

Popular nasal decongestant doesn't actually relieve congestion

PlayStation controller and acoustic messaging: How the missing Titanic tourist sub works

PlayStation controller and acoustic messaging: How the missing Titanic tourist sub works

US ambassador visits Wall Street Journal reporter detained in Russia on charges of espionage

WATCH: Why do bright lights make us see spots?

leisure time

explore

explore

FDA approval of Sarepta Duchenne genetic therapy gives me hope

4 dead, 2 in stable condition in Philadelphia shooting: Police

Walensky prepares to leave CDC — and Congress — behind

Masked assailants attack a journalist and a lawyer in Russia's Chechnya province

In Memoriam: Notable people who died in 2023

Kremlin open to talks over potential prisoner swap involving detained US reporter Evan Gershkovich

Activists slam private health insurers over coverage restrictions

Long Covid needs a new name — and a new frame

New air purifier tech could be key to improving indoor air quality

Generate Biomedicines machine learning biotech raises $273M

entertainment

Long Covid needs a new name — and a new frame

US recommends Americans reconsider traveling to China due to arbitrary law enforcement, exit bans

Legitimacy of 'customer' in Supreme Court gay rights case raises ethical, legal flags

FDA proposes changes to key medical devices approval pathway

Leon Gautier, last member of French D

US ambassador visits Wall Street Journal reporter detained in Russia on charges of espionage

focus

Wikipedia

hotspot

hotspot