Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite ...
Eli Lilly (NYSE:LLY) shares edged 0.9% lower in premarket trading on Thursday after the U.S. Food and Drug Administration postponed its decision on the company’s weight-loss pill until April 10. The ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
BERLIN, Jan 27 (Reuters) - Roche's experimental obesity drug, which works in a similar way to Eli Lilly's Zepbound, produced ...
A case targeting alleged fraud around the safety risk of a blockbuster diabetes drug is leveraging the RICO pathway and could ...
Public Citizen filed a lawsuit against the Trump administration in the U.S. District Court for the District of Columbia ...
Eli Lilly and Co. has received the U.S. Food and Drug Administration’s breakthrough therapy designation for a drug in development to treat certain ovarian cancer patients. The Indianapolis-based ...
Dec 12 (Reuters) - Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation ‌of Eli Lilly's experimental weight‑loss pill, after the company ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Novo Nordisk has global metabolic leadership, an oral GLP-1 program, and a stock price below $50 after a retail-driven ...