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

Prescription Digital Therapeutics

- PMLiVE

Sandoz finally wins FDA approval for Neulasta biosimilar

Follows a three year wait since initial rejection in 2016

- PMLiVE

Aveo’s tivozanib is knocked back by FDA once again

Company says it will delay any regulatory filing until first quarter next year

- PMLiVE

MD Anderson exec Stephen Hahn to be nominated FDA commissioner

US President Trump scouts well-known oncology expert to lead agency

- PMLiVE

Vertex scores FDA approval for CF triple therapy Trikafta

Decision comes only a few months after therapy was filed

Roche Basel Switzerland

Roche scores another FDA approval for Xofluza

Expands use to patients at high risk of flu-related complications

- PMLiVE

Novartis bags US okay for Lucentis follow-up Beovu in wet AMD

Head-to-head trial with rival Eylea could boost sales

- PMLiVE

Gilead builds case for Descovy PrEP after FDA approval

Reported statistically significant improvements in kidney function

- PMLiVE

Gilead claims FDA okay for Descovy as second PrEP option

Can now push new indication before generics dent franchise

- PMLiVE

Sarepta rival NS Pharma files Duchenne drug with FDA

Another blow for Sarepta following FDA rejection earlier this year

It’s the guns, stupid

Gun violence in the US – a public health issue – can be better understood through three points

- PMLiVE

GSK and Apotex join generic Zantac recalls as carcinogen concerns mount

Novartis’ generic unit Sandoz halted distribution last week

- PMLiVE

Acacia eyes February FDA verdict for refiled nausea drug Barhemsys

Back on track after being turned down twice

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links