STATOpinion

The FDA, urged to avoid controversy, creates a new headache with attack against UniQure

Recent decisions at the FDA threaten to turn its disagreements with the drugmaker UniQure into another political headache for ...
STAT

UniQure plans to seek approval for Huntington’s therapy still blocked by FDA

UniQure said Monday that plans to seek approval for its Huntington’s disease treatment with the Food and Drug Administration ...
STAT

Breaching the IBD efficacy ceiling, and sham surgeries

Spyre Therapeutics CEO Cameron Turtle talks about the search for an IBD treatment on this week's "The Readout LOUD." ...
STAT

FDA is ‘not convinced’ UniQure’s Huntington’s therapy has benefit, senior official says

The FDA believes that an experimental therapy for Huntington’s disease from UniQure wasn't providing benefit for patients, a senior official told STAT.
STAT

A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA

Drugmakers thought they had the FDA's buy-in to approve a therapy to treat a type of cancer that can quickly turn deadly. The agency, however, rejected it.
STAT

Listen: FDA turmoil, election intrigue, AI, and more

They ran through a menu of takes on biotech stock performance, M&A, Food and Drug Administration turmoil, election intrigue, ...
STAT

The extremism of the FDA’s Marks and Prasad has come with costs

With the current leadership of the FDA, the rare-disease community is suffering whiplash. Drugmakers are frustrated. And investors are sitting on their wallets.
STAT

Xenon’s seizure drug study reads out soon. Here’s what to expect

Xenon Pharmaceuticals is developing a drug for the most common type of seizure experienced by people with epilepsy. Here's ...
STAT

‘This is an industry that everyone [bleeping] hates’

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...
STAT

Insmed basks in the success of its lung disease drug — and prepares for what’s next

Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and ...
STAT

New stakes in the vaccine dispute and a boost for biotech

Allison DeAngelis is the East Coast biotech and venture capital reporter at STAT, reporting where scientific ideas and money meet. She is also co-host of the weekly biotech podcast, The Readout Loud.
STAT

Pharma tariffs, and a ‘sunshine day’ for biotech stocks

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70. Adam Feuerstein is a ...