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.

A resourceful solution to repurpose waste and nourish farmland, or a poisonous and permanent mistake? Depending on whom you ...

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

Tiny highly uniform magnetic fields are known to pervade the universe, influencing various cosmological processes. To date, however, the physical mechanisms underpinning the generation of these fields ...

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.

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.

FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong mechanistic and biological plausibility supporting the use of ...