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- PMLiVE

Lilly’s donanemab shows promise in early symptomatic Alzheimer’s comparator study

Brain amyloid clearance was achieved in 37.9% of patients treated with the investigational antibody

- PMLiVE

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

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

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AstraZeneca to acquire Neogene Therapeutics in $320m deal

The agreement will build the company’s pipeline of cell-based cancer treatments

- PMLiVE

AstraZeneca and C4X Discovery sign exclusive $403m licensing deal

The collaboration aims to develop an oral therapy for inflammatory and respiratory diseases

- 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

AstraZeneca receives CHMP recommendations for Imfinzi, Enhertu and Lynparza

The treatments are for use in prostate, biliary tract and advanced gastric cancer

- PMLiVE

ICR calls for further discussions following NICE’s rejection of breast cancer drug

Olaparib has been shown to cut the risk of cancer recurrence and improve survival

- 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

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