To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of ...

AnaptysBio offers significant upside, with fair value estimates nearly double its current market cap if RA approval is ...

Cheng Xin / Getty Images Shares of Moderna surged to lead S&P 500 gainers in early afternoon trading Tuesday, hours after the Food and Drug Administration (FDA) issued new guidance for COVID-19 ...

WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data ... guidance mirrors those restrictions.

“We want some good clinical data.” Earlier this year, the Trump administration sought for drug manufacturer Novavax to commit to conducting a new clinical trial on its coronavirus vaccine ...

The FDA chief has also expressed concerns about the lack of data supporting Novavax’s COVID vaccine, calling for more studies into its effectiveness before approving it. "The big Novavax 2020 ...

Until recently, AI has mostly been used to accelerate the process of discovering promising new drug candidates, thanks to its ability to process vast amounts of data quickly and accurately.

RIGL is a profitable, three-drug company ... but might take time to produce some data, RIGL hasn't provided much guidance on that front. With the RIPK1 inhibitor program partnered with Eli ...

The FDA’s latest draft ... The updated guidance 1 offers unprecedented clarity on eligibility and evidentiary requirements and clinical endpoint expectations—empowering biopharma companies to expedite ...

This document is essential for ensuring that the data submitted is accurate, complete, and consistent with FDA requirements. It includes technical specifications, validation rules, and guidance on ...

The U.S. Food and Drug Administration has canceled an upcoming meeting with ... Selecting strains for the flu vaccine is usually performed in February or March using data from the World Health ...