The CRL for bitopertin EPP affects the regulatory pathway and potential market entry. The accelerated approval process ...

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.

President Donald Trump’s recent visit to Iowa highlighted the importance of strong energy and economic future, it is worth underscoring the critical role a competitive freight rail system plays in ...

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.

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

Moderna Inc.’s shares fell after US regulators refused to review its novel mRNA flu vaccine, creating regulatory chaos for ...

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

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.

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...

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

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.