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

daprodustat

- PMLiVE

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

- PMLiVE

GSK’s new global survey exposes lupus treatment gaps

The findings show opportunities to address organ damage risk for early stage lupus patients

- PMLiVE

FDA approves first gene therapy for adults with haemophilia B

CSL’s Hemgenix allowed patients to produce mean factor IX activity of 39% at six months

- PMLiVE

Roche’s high-throughput monkeypox test approved for emergency use by FDA

The tests will be conducted on the company’s 6800/8800 cobas systems

- PMLiVE

FDA advisory committee recommends Ardelyx’s Xphozah for chronic kidney disease

The phase 3 trials supporting the submission met all primary and key secondary endpoints

- PMLiVE

FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

An overall response rate of 31.7% was demonstrated, including five complete responses

- PMLiVE

Sanofi/GSK’s next-generation COVID-19 booster granted EC approval

Two trials compared the immune response induced by VidPrevtyn Beta with approved vaccines

- PMLiVE

AZ and Avillion’s asthma rescue treatment recommended by FDA Advisory Committee

PT027 significantly reduced the risk of severe asthma exacerbations

regeneron headquarters

Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy

- PMLiVE

Pfizer’s multiple myeloma treatment granted FDA Breakthrough Therapy Designation

Elranatamab-treated patients achieved an overall response rate of 61% in a phase 2 trial

- PMLiVE

Boehringer and Lilly’s Jardiance shows promise in phase 3 chronic kidney disease trial

Jardiance reduced disease progression and cardiovascular death by 28%

- PMLiVE

GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links