DF-003 is the first ALPK1 inhibitor to successfully complete a first-in-human Phase 1 study and has now entered a Phase 1b clinical trial in patients with ROSAH syndrome (NCT06395285), where it is ...

The FDA granted fast track designation (FTD) to IBI3003, a first-in-class trispecific antibody, for the treatment of patients ...

WASHINGTON—Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

The U.S. Food and Drug Administration has delayed reviews of several drugs selected for the Trump administrations new ...

The FDA grants Fast Track designation to BNT113 for treating HPV16+ head and neck squamous cell carcinoma expressing PD-L1 in the first-line setting.

The FDA has delayed reviews of two drugs in the Trump administration's fast-track program due to safety concerns, including a ...

The U.S. Food and Drug Administration (FDA) announced that it will fast-track review of nine experimental drugs. The move is part of a Trump administration program aimed at prioritizing medicines that ...

・As per Reuters, both the drugs have multibillion-dollar potential. ・FDA expects Merck to submit its applications for Enlicitide in April and for Sac-TMT in October or November next year. ・Other drugs ...

FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...

Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease. MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of ...