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.

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

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 ...

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

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 ...

Thanks to President Trump’s One Big Beautiful Bill Act, those with existing Parent PLUS loans who don't consolidate before ...

The Supreme Court recently directed the Telangana Forensic Sciences Laboratory to submit before it in a sealed cover the ...

Opinion: Minority members of limited liability companies should work to draft operating agreements that allow them more control over the agreements’ provisions.

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 ...