The U.S. Food and Drug Administration is likely to come under tighter scrutiny over vaccine development and safety testing ...

Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a news release. The agency's proposed order would remove oral phenylephrine from the "monograph" of ...

SMi Group Reports: Following the FDA’s release of a ... [centerforbiosimilars.com] Also in recent news were statements made by the chair of this year’s two-day conference; Richard DiCicco ...

Following the initial detection, the agency sought to identify the specific raw ingredient in the product contaminated with Sudan dye, a red synthetic dye that is banned in Taiwan for use in ...

Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture ...

Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture ...

RFK Jr has vowed to shake up the FDA, but the CBER head said support for the agency’s public health mission continues.

will host a conference call to discuss feedback received from its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). The conference call will be held on Monday ...

The U.S. Food and Drug Administration’s (FDA) head of vaccine safety says that President-elect Donald Trump’s embrace of ...

The Company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe, which could appeal to an even larger market in terms of both patients and ...