FDA

Racial bias Pain Management
Pharmalot

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

By Ed Silverman

FDA
Biotech

FDA rejects Immunomedics breast cancer drug, extending long regulatory drought

By Adam Feuerstein

Gottlieb Generic Drugs
Biotech

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

By Adam Feuerstein

Pill illo
Pharmalot

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

By Ed Silverman

Compounding Drugs
Pharmalot

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

By Ed Silverman

A photo of Scott Gottlieb
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

Prostate Cancer
Biotech

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

By Adam Feuerstein

Cancer Chemotherapy
Pharmalot

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

By Ed Silverman

Kefauver-Harris Drug Amendments
Opinions Plus

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

By Mary J. Ruwart

Sickle Cell meds illo
Adam's Take

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

By Adam Feuerstein

FDA; Drug Administration campus
Biotech

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

By Adam Feuerstein

One bright pill
Opinions Plus

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

By Vijay Ramakrishnan and Edwin P. Ching

Paxil
First Opinion

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

By Stephen Soumerai and Ross Koppel

Scott Gottlieb talking
Pharmalot

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

By Ed Silverman

Celgene
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

Off-label Discussions
First Opinion

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

By John Osborn and Seth Ray

AbbVie California
Pharmalot

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

By Ed Silverman

Valeant Addyi
Pharmalot

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

By Ed Silverman

Pharmalot
Pharmalot

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

By Ed Silverman

Pharmalot

Pharmalittle: Shire rejects latest Takeda offer; Greek parliament ends Novartis bribery probe

By Ed Silverman

STAT Plus panel
Biotech

Why are some of New York’s top investors bullish on biotech? The science is getting better

By Adam Feuerstein

Compounding Pharmacy
Pharmalot

FDA moves to address disputes between drug makers and compounders

By Ed Silverman

Pharmalot

Pharmalittle: CVS taps an Eli Lilly exec to run its PBM; Glaxo pharma chief cuts his budget

By Ed Silverman

Patient Advocacy Funding
Pharmalot

Millions in fines are adding up as clinical trial information goes unreported

By Ed Silverman

Pharmalot

Pharmalittle: Glaxo wins a reprieve for Advair; AstraZeneca delays lung cancer trial results

By Ed Silverman

Sarepta
Biotech

Sarepta to seek FDA approval for its second Duchenne’s drug by year’s end

By Adam Feuerstein

Mail bag
Biotech

You have questions on genome-editing. We have answers

By Adam Feuerstein and Sharon Begley

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