Fda

First Opinion

FDA’s research guidance will help take guesswork out of drug dosing in newborns

By Michael Cohen-Wolkowiez and Kanecia Zimmerman

Pharmalot

Pharmalittle: Mallinckrodt mulls restructuring as opioid trial nears; the next FDA commissioner will be …

By Ed Silverman

Pharmalot

Pharmalittle: Two drug makers may settle opioid case; FDA hands Sarepta a surprising setback

By Ed Silverman

First Opinion

FDA should use its existing program to qualify new tools for drug safety testing

By Elizabeth Baker

Biotech

Sarepta stumbles on FDA rejection of a new drug to treat Duchenne muscular dystrophy

By Adam Feuerstein

First Opinion

Novartis violated FDA’s sacred principle: In God we trust, all others must bring data

By Robert M. Califf

First Opinion

State drug importation programs will work with the FDA, not outside of it

By Jane Horvath

Pharmalot

Scott Gottlieb walks through the revolving door to the Pfizer board

By Ed Silverman

Adam's Take

The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies

By Adam Feuerstein

First Opinion

FDA’s overreach will harm compounding pharmacies and the patients they serve

By Scott Brunner

Pharmalot

Drug maker tells FDA there weren’t enough people to clean equipment due to a dancing holiday

By Ed Silverman

First Opinion

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

By Diane Dorman

Pharma

At $2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug

By Adam Feuerstein

First Opinion

How Insys undermined an FDA effort to protect the public from dangerous opioids

By William Fleischman and Joseph S. Ross

First Opinion

Substandard control arms question the utility of some new cancer drugs

By Talal Hilal

Biotech

FDA approves first new drug developed for women with postpartum depression

By Adam Feuerstein

First Opinion

I hope the departure of ‘tech-savvy’ Gottlieb won’t undo progress at the FDA

By Pratap Khedkar

Pharmalot

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

By Ed Silverman

Biotech

FDA rejects Immunomedics breast cancer drug, extending long regulatory drought

By Adam Feuerstein

Biotech

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

By Adam Feuerstein

Pharmalot

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

By Ed Silverman

Pharmalot

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

By Ed Silverman

Pharmalot

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

By Ed Silverman

Pharmalot

Pharmalittle: Trump to give speech today on drug pricing; FDA approves a novel, but pricey flu drug

By Ed Silverman

Biotech

Clovis, with new study data, hopes to be first to develop a PARP for prostate cancer

By Adam Feuerstein

Pharmalittle: Rise in drug costs for large employers slows; experimental TB vaccine proves effective

New Vertex cystic fibrosis drug approved, extending treatments to 90% of patients

FDA bid to bolster generic competition and combat shortages isn’t working — yet

Pharmalittle: Judge orders pause in suits against Purdue and Sacklers; Teva must face opioid trial

FDA’s research guidance will help take guesswork out of drug dosing in newborns

Pharmalittle: Mallinckrodt mulls restructuring as opioid trial nears; the next FDA commissioner will be …

Pharmalittle: Two drug makers may settle opioid case; FDA hands Sarepta a surprising setback

FDA should use its existing program to qualify new tools for drug safety testing

Sarepta stumbles on FDA rejection of a new drug to treat Duchenne muscular dystrophy

Novartis violated FDA’s sacred principle: In God we trust, all others must bring data

State drug importation programs will work with the FDA, not outside of it

Scott Gottlieb walks through the revolving door to the Pfizer board

The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies

FDA’s overreach will harm compounding pharmacies and the patients they serve

Drug maker tells FDA there weren’t enough people to clean equipment due to a dancing holiday

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

At $2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug

How Insys undermined an FDA effort to protect the public from dangerous opioids

Substandard control arms question the utility of some new cancer drugs

FDA approves first new drug developed for women with postpartum depression

I hope the departure of ‘tech-savvy’ Gottlieb won’t undo progress at the FDA

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

FDA rejects Immunomedics breast cancer drug, extending long regulatory drought

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

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

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

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

Pharmalittle: Trump to give speech today on drug pricing; FDA approves a novel, but pricey flu drug

Clovis, with new study data, hopes to be first to develop a PARP for prostate cancer