・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 ...

Sept 8 (Reuters) - (This Sept. 8 story has been corrected to add the missing words 'from the risks' to the FDA statement, in paragraph 7) The U.S. Food and Drug Administration plans to fast-track ...

The FDA has begun accepting applications for a priority pathway designed to slash review times to between one and two months, giving developers of medicines that align with U.S. national health ...

Dec 9 (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application. The approval for the ...

(Reuters) -The U.S. Food and Drug Administration plans to fast-track reviews of four tobacco firms' nicotine pouches in a pilot program launching on Monday, amid pressure from the Trump administration ...