The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...

While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in ...

After GSK’s return of Wave Life Sciences’ WVE-006 as well as the mid-stage failure of Korro Bio’s candidate, the alpha-1 ...

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, ...

Opening up about drug pricing decisions is not optional for biopharma anymore. For the sake of credibility, companies should ...

With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one ...

Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.

A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data ...

Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.

AstraZeneca's $15 billion pledge to its China operations highlights the country's advantages. But other regions are also hoping to host more clinical studies.

In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.

Cellares, which last year became the first company to receive the FDA's new advanced manufacturing technology designation, ...