FDA

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

Pharmalot By Ed Silverman

Scott Gottlieb walks through the revolving door to the Pfizer board

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

First Opinion By Diane Dorman

Don’t let the maker of a buprenorphine drug abuse the Orphan Drug Act

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

First Opinion By Talal Hilal

Substandard control arms question the utility of some new cancer drugs

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

Pharmalot By Ed Silverman

Lawmakers ask FDA to explain steps to contain contaminants in blood pressure drugs

Biotech By Adam Feuerstein

FDA rejects Immunomedics breast cancer drug, extending long regulatory drought

Biotech By Adam Feuerstein

Shutdown has Aimmune waiting on FDA on multiple fronts — a sign of broader delays for biopharma

Pharmalot By Ed Silverman

As pharma seeks more orphan drug designations, FDA fails to assess important needed info

Pharmalot By Ed Silverman

AmerisourceBergen suffers another setback with its ‘real doozy’ of a compounding business

Pharmalot By Ed Silverman

Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl