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- PMLiVE

Wakix

- PMLiVE

GSK’s personalised cancer drug Tafinlar set for European approval

Regulatory advisors recommend the melanoma drug be licensed

- PMLiVE

First mAb biosimilars set for European approval

Celltrion and Hospira's versions of J&J's blockbuster Remicade recommended by CHMP

- PMLiVE

EMA commits to disclosure of data from trials

Seeks feedback on clinical trial data access policy

- PMLiVE

Alexion begins work on new global headquarters

Rare diseases drug company will move to new US site in 2015

- PMLiVE

Celgene wins expanded EU approval for cancer drug Revlimid

Approved for use in patients with rare blood disorder

- PMLiVE

US charity calls for release of diabetes drug data

American Diabetes Association demands review of incretin-based medicines linked to pancreatic cancer

- PMLiVE

EMA seeks comment on final biosimilar guidance

Outlines thinking on non-clinical and clinical development requirements

- PMLiVE

Celgene’s Revlimid wins US lymphoma approval

FDA recommends extra indication for blockbuster cancer drug

- PMLiVE

FDA gives priority review status to BMS/ AZ’s metreleptin

Former obesity prospect has potential in the rare disease lipodystrophy

- PMLiVE

EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more

- PMLiVE

GSK/ Valeant’s Trobalt set for EU restrictions

Eye concerns prompt CHMP to recommend last-line use for the epilepsy drug

- PMLiVE

Orphan status in US for Astellas/ Basilea antifungal

Isavuconazole is being developed as a treatment for invasive aspergillosis

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