Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

linaclotide

- PMLiVE

FDA refuses to back Gilead’s two HIV drugs

Agency questions quality of testing procedures for elvitegravir and cobicistat

- PMLiVE

Lilly expects to submit five drugs for US approval in 2013

Hopes FDA submissions will help offset patent losses for Zyprexa and Cymbalta

- PMLiVE

FDA stung by damning fraudulent research report

Agency accused of leaving untested drugs on the market

- PMLiVE

FDA bars generic version of Purdue’s painkiller OxyContin

New abuse-deterrent formulation means original version no longer has positive benefit-to-risk profile

- PMLiVE

FDA approves return of morning sickness drug for pregnant women

Regulator confirms safety of Diclegis – formerly known as Bendectin

Bayer symbol

Bayer’s riociguat fast-tracked by FDA

Could provide oral option in pulmonary arterial hypertension market

- PMLiVE

FDA delays GlaxoSmithKline’s pandemic flu vaccine

More time needed due to "administrative" issue

FDA says final mobile app guidance just weeks away

And tells Congress only a fraction of mobile apps will need regulating

- PMLiVE

Merck & Co’s sugammadex delayed in US

FDA says it needs more time to review application

- PMLiVE

FDA investigates pancreas risk of diabetes drugs

Products from Merck & Co, BMS, AZ, Novo Nordisk, Boehringer, Amylin and Takeda all involved

Novartis building

FDA deems Novartis lung cancer drug a “breakthrough therapy”

LDK378 will have accelerated passage through development

- PMLiVE

FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links