Health By Dylan Scott FDA to require strong warnings about combining pain pills with anxiety medication
Health By Andrew Joseph New Vertex cystic fibrosis drug approved, extending treatments to 90% of patients
Health By Bob Tedeschi and Sheila Kaplan He’s 20. Has brain cancer. And is caught in the crossfire between the FDA and a renegade doctor
Adam's Take By Adam Feuerstein Applied Therapeutics’ muted response to a clinical hold speaks volumes
Adam's Take By Adam Feuerstein FDA refuses application for HIV drug from CytoDyn, raising more questions about its credibility
Biotech By Adam Feuerstein Zogenix wins approval for new drug to treat rare type of childhood epilepsy
Adam's Take By Adam Feuerstein CytoDyn says lead HIV drug was not filed for FDA approval, as previously claimed
Pharma By Adam Feuerstein Bristol’s MS drug approval is good news for shareholders but patients will have to wait
Pharmalot By Ed Silverman Pharmalittle: Rise in drug costs for large employers slows; experimental TB vaccine proves effective
Pharmalot By Ed Silverman FDA bid to bolster generic competition and combat shortages isn’t working — yet
Pharmalot By Ed Silverman Pharmalittle: Judge orders pause in suits against Purdue and Sacklers; Teva must face opioid trial
First Opinion By Michael Cohen-Wolkowiez and Kanecia Zimmerman FDA’s research guidance will help take guesswork out of drug dosing in newborns
Pharmalot By Ed Silverman Pharmalittle: Mallinckrodt mulls restructuring as opioid trial nears; the next FDA commissioner will be …
Pharmalot By Ed Silverman Pharmalittle: Two drug makers may settle opioid case; FDA hands Sarepta a surprising setback
First Opinion By Elizabeth Baker FDA should use its existing program to qualify new tools for drug safety testing
Biotech By Adam Feuerstein Sarepta stumbles on FDA rejection of a new drug to treat Duchenne muscular dystrophy
First Opinion By Robert M. Califf Novartis violated FDA’s sacred principle: In God we trust, all others must bring data
First Opinion By Jane Horvath State drug importation programs will work with the FDA, not outside of it
Adam's Take By Adam Feuerstein The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies
First Opinion By Scott Brunner FDA’s overreach will harm compounding pharmacies and the patients they serve
Pharmalot By Ed Silverman Drug maker tells FDA there weren’t enough people to clean equipment due to a dancing holiday
Pharma By Adam Feuerstein At $2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug
First Opinion By William Fleischman and Joseph S. Ross How Insys undermined an FDA effort to protect the public from dangerous opioids
Biotech By Adam Feuerstein FDA approves first new drug developed for women with postpartum depression
First Opinion By Pratap Khedkar I hope the departure of ‘tech-savvy’ Gottlieb won’t undo progress at the FDA