STAT

Is Aldeyra Therapeutics waving red flags with consequences?

Welcome back! Aldeyra Therapeutics is complaining about short sellers in the run-up to an FDA approval decision. The Vertex era of frictionless commerce is coming to an end. And with Doug Ingram’s ...
STAT

Xenon Pharmaceuticals’ seizure drug shows strong efficacy in late-stage trial

Xenon Pharmaceuticals said its treatment for a common type of seizure disorder significantly reduced the frequency of those seizures compared to a placebo.
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 ...
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

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

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

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

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

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 permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt

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 ...