While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in ...
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.
Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic ...
Opening up about drug pricing decisions is not optional for biopharma anymore. For the sake of credibility, companies should ...
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 what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, ...
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one ...
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in ...
New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
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.
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