Disc Medicine has received a CRL from the US FDA concerning its New Drug Application (NDA) for bitopertin for EPP.

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.

Type Dynamics assessment gives MBTI-qualified practitioners a way to move beyond the four-letter code and into Jung's 8 ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

Explore a letter of comfort, its uses in finance, and how it differs from guarantees. Learn how these documents can provide assurance without legal obligation.

FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong ...

As AI adoption accelerates across enterprises, applications teams are under pressure to deliver faster, more personalized, ...

This is my first formal op-ed on politics, social issues, or any public matter and I approach it from proximity rather than ...

Given Trump’s well-documented pattern of attacking anyone who contradicts him, firing officials who deliver inconvenient ...

Eisgruber sent his 10th annual State of the University letter, titled “From Growth to Focus,” to faculty, students and staff on Monday, Feb. 2.

A press freedom group accused a prosecutor of violating an ethics rule by not telling a judge about a law limiting searches for journalistic work product.

With matric results released, the class of 2025 faces the daunting task of applying for tertiary education. Discover essential tips and guidance to navigate the application process successfully.