Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public […]
Read MoreGOP Sen. Johnson investigating FDA rare disease drug rejections
WASHINGTON — Sen. Ron Johnson (R-Wis.) said he is investigating the Food and Drug Administration’s rejections of rare disease treatments. The Wisconsin Republican is requesting denial letters, called complete response letters, […]
Read MoreCytokinetics heart drug wins FDA approval, the biotech’s first
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech […]
Read MoreTracy Beth Høeg will lead FDA Center for Drug Evaluation and Research
WASHINGTON — Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research, according […]
Read MoreSTAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable […]
Read MoreFDA approves Blenrep, a GSK blood cancer drug with unusual history
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.45. The Food and Drug Administration on Thursday delivered a split decision […]
Read MoreFDA declares Novo Nordisk drug manufacturing plant out of compliance
A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the Food and Drug Administration standards, a serious designation that could […]
Read MoreHow much can the FDA really rein in pharma ads?
This article first appeared in the newsletter Your Local Epidemiologist.Pharmaceutical ads in the United States are annoying. Absurd. And almost uniquely American. In fact, only one other high-income country in […]
Read MoreFDA leaders moving to stop advisory committee reviews of drugs
FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions […]
Read MoreFDA ends emergency use authorization for Covid vaccines
WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the […]
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