Biotech stocks have slumped 15% since Donald Trump won his second presidency. That's because Trump comes with a lot of ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
The Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) issued a ...
The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...
Patrizia Cavazzoni, leader of the FDA's Center for Drug Evaluation and Research, is leaving the agency on Jan. 18.
Endpoints Weekly reports on iECURE's gene therapy success for OTC deficiency, FDA CDER director Patrizia Cavazzoni's departure, and Verdiva Bio's $411M launch with Sciwind assets.
Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.
The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is ...
FDA's Patrizia Cavazzoni to retire as CDER chief in 2nd senior official's departure in span of weeks
The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire ...
According to CDER Director Patrizia Cavazzoni, CDER’s new Center for Real-World Evidence Innovation represents a major step ...
It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched ...
The agency affirmed the use of biopsies for biomarker-driven trials but cautioned against optional biopsies that offer little value to the patient or trial.
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