The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency.

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and ...

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its ...

One surprising consequence of the coronavirus pandemic and its work-from-home zeitgeist? Biopharma companies have been compelled to rethink and perhaps even improve how they operate their businesses.

The FDA's Center for Drug Evaluation and Research, or CDER, has established a new center for communication between CDER staff and stakeholders involved in clinical trials, according to an April 15 ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the launch of a new hub focused on promoting innovation in clinical trials. The CDER outlined ...

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies ...

The US Food and Drugs Administration (FDA) has confirmed that its director of the Centre for Drug Evaluation and Research (CDER), Patrizia Cavazzoni, has announced her resignation ahead of Donald ...

The Danish American who doubted Covid shots is meant to lead drug regulation – but has focused on vaccines ...

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives. FDA’s Center for Drug Evaluation and Research (CDER) published an updated CDER Drug Safety Priorities: ...