Lilly to submit obesity pill after hitting goal in third late-stage trial

In people with diabetes and obesity, orforglipron led to weight loss near what people without diabetes experienced in prior testing.

FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.

The future of neuroscience drug development

Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

Stealth secured a new agency review of its experimental therapy elamipretide after a rejection this year. The result could carry broader consequences.

FDA suspends license for Valneva’s chikungunya shot

The agency said it had become aware of more reports of serious adverse events, leading center director Vinay Prasad to conclude the vaccine is no longer safe for its intended use.

FDA approves Ionis’ hereditary angioedema drug

Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition. Ionis set its list price at $57,462 per dose.

US, EU agree to terms of framework trade pact

The countries documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, pharmaceuticals and semiconductors.

Trump’s tariffs, “distorted” U.S. drug market on the mind of Sandoz’s CEO

Pfizer Covid vaccine for young children may not be renewed by FDA