FDA

Mother and child

Biotech

FDA approves first new drug developed for women with postpartum depression

By Adam Feuerstein

Smartphone

First Opinion

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

By Pratap Khedkar

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Racial bias Pain Management

Pharmalot

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

By Ed Silverman

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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

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A photo of Scott Gottlieb

Pharmalot

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

By Ed Silverman

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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