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

US Congress

- PMLiVE

Immunomedics craters after FDA rejects breast cancer ADC

Regulator wants to see more data on manufacturing

Sanofi reception

FDA adcomm split on Sanofi’s type 1 diabetes drug

Concerns rose after Zynquista-treated patients showed an eight-fold increase in DKA

- PMLiVE

Evenity back on track with FDA panel blessing in osteoporosis

US drugs regulator first rejected the drug due to cardiovascular concerns

- PMLiVE

FDA expecting boom in cell and gene therapies

Pledges clampdown on developers working outside regulations

- PMLiVE

FDA moves into crisis mode as shutdown drags on

New drug appraisals already being affected

- PMLiVE

US government shutdown leaves FDA running on empty

Funding row means shutdown could break 21 day record

- PMLiVE

FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted

- PMLiVE

FDA clears Sandoz and Pear’s Opioid Use Disorder app

The app incorporates CBT to improve high relapse rates

- PMLiVE

Pfizer claims rapid FDA nod for Lorbrena

Green light is latest in a string of cancer drug approvals

- PMLiVE

AcelRX’s potent opioid tablets set to win FDA backing for pain relief

Panel voted 10 to 3 in favour of the treatment

- PMLiVE

Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

- PMLiVE

Alnylam seeks fast-track filing with biomarker data

Early filing reflects FDA desire for faster approvals

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links