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 MoreA restless leg syndrome drug led me to compulsive gambling
I was a tenured professor, a published novelist, and a married father of two sons when I lost everything — because of a drug I was prescribed for a condition most people […]
Read MoreRoche moves obesity drug to pivotal trials after mid-stage success
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71. Roche plans to launch Phase 3 studies of its leading obesity […]
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 MoreSolicitor general urges SCOTUS to hear case on generic drug labelsSolicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access
In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding […]
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 MoreTrump administration embraces Medicare drug negotiations
WASHINGTON — On Tuesday, the Trump administration celebrated drug price cuts it had secured through a Democrat-created program — despite Republicans’ longstanding antipathy toward the policy. The Inflation Reduction Act, […]
Read MoreFDA’s top drug regulator, George Tidmarsh, resigns amid probe
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 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 […]
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