Fda

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

Pharmalot

Cancer trials that rely on surrogate endpoints overlook quality-of-life issues

By Ed Silverman

Opinions Plus

A 1962 law slowed drug development. Changing it could slash drug prices

By Mary J. Ruwart

Adam's Take

Global Blood’s FDA filing plan for a sickle cell drug is riskier than you think

By Adam Feuerstein

Biotech

Amicus wanted to fast-track a Pompe disease approval filing. The FDA said no

By Adam Feuerstein

Opinions Plus

Inappropriate ‘interchangeability’ requirement for biosimilars will cost the U.S. billions

By Vijay Ramakrishnan and Edwin P. Ching

First Opinion

FDA’s continuing use of ‘black box’ for antidepressants ignores the harms of this warning

By Stephen Soumerai and Ross Koppel

Pharmalot

FDA eyes new ways to lower some drug costs and boost consumer access

By Ed Silverman

Adam's Take

Celgene is perking up. Here’s what needs to happen for the momentum to continue

By Adam Feuerstein

Adam's Take

Red flags fly over Anavex: What’s stopping the drug maker from enrolling U.S., European patients in trials?

By Adam Feuerstein

First Opinion

FDA allows off-label health care economic discussions. Is there more to come?

By John Osborn and Seth Ray

Pharmalot

AbbVie is reprimanded by the FDA for failing to properly probe death complaints

By Ed Silverman

Pharmalot

The Addyi female libido pill has fewer restrictions in Canada. Is the U.S. next?

By Ed Silverman

Pharmalot

A tip from the FDA: don’t use the same equipment to make drugs and pesticides

By Ed Silverman

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

Cancer trials that rely on surrogate endpoints overlook quality-of-life issues

A 1962 law slowed drug development. Changing it could slash drug prices

Global Blood’s FDA filing plan for a sickle cell drug is riskier than you think

Amicus wanted to fast-track a Pompe disease approval filing. The FDA said no

Inappropriate ‘interchangeability’ requirement for biosimilars will cost the U.S. billions

FDA’s continuing use of ‘black box’ for antidepressants ignores the harms of this warning

FDA eyes new ways to lower some drug costs and boost consumer access

Celgene is perking up. Here’s what needs to happen for the momentum to continue

Red flags fly over Anavex: What’s stopping the drug maker from enrolling U.S., European patients in trials?

FDA allows off-label health care economic discussions. Is there more to come?

AbbVie is reprimanded by the FDA for failing to properly probe death complaints

The Addyi female libido pill has fewer restrictions in Canada. Is the U.S. next?

A tip from the FDA: don’t use the same equipment to make drugs and pesticides

FDA

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