NasdaqGS:AMGNBiotechs
FDA Tavneos Proposal Puts Amgen Trial Integrity And Growth Story Under Review
The FDA's Center for Drug Evaluation and Research has proposed that Amgen withdraw its drug Tavneos, citing untrue statements of material facts and possible data manipulation in clinical trial data.
Regulators also questioned whether existing evidence is sufficient to support Tavneos's effectiveness.
The proposal raises concerns about Amgen's regulatory controls, data transparency, and risk oversight as the company grows in biopharmaceuticals.
For investors watching Amgen, ticker...