STAT3h
Patrizia Cavazzoni, head of FDA’s drug center, to leave the agency
Patrizia Cavazzoni, leader of the FDA's Center for Drug Evaluation and Research, is leaving the agency on Jan. 18.
BioPharma Dive1h
Patrizia Cavazzoni, key FDA official, to leave agency
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 ...
STAT2h
In debate over obesity medications, FDA shifts toward importance of drugs in subtle ways
The changes reflect “a cultural shift” around obesity medications, said Diana Zuckerman, president of the nonprofit National ...
FiercePharma5h
FDA cancels adcomm in 'positive' sign for Exelixis’ Cabometyx bid in neuroendocrine tumors: analyst
On second thought, the FDA figures it no longer needs to discuss Exelixis’ application for Cabometyx in neuroendocrine tumors ...
FiercePharma3h
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 ...
Outlook For These Biotechs Brightens As FDA Ushers In New Rules For Sector
Biotech stock GeneDx broke out after the FDA issued its first AI rules for medical devices. Globus Medical and GeneDx are in ...
Healio8m
FDA grants priority review to nipocalimab for myasthenia gravis
The FDA has granted priority review to a Biologics License Application for nipocalimab to treat individuals with generalized myasthenia gravis who are antibody positive, according to the manufacturer.
Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
FDA sets limits for lead in many baby foods as California disclosure law takes effect
The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the ...
Pizza Recall Update As FDA Sets Risk Level Over Plastic Contamination
The recalled "Connie's Thin Crust Cheese Pizza" was issued a Class II risk level by the FDA, the second-most severe risk ...
4D Molecular, FDA agree on phase 3 design for DME candidate
D Molecular Therapeutics reaches agreement with FDA for phase 3 trial design of DME candidate 4D-150, showing promising ...