The FDA approved Amgen ’s anti-CD19 therapy Uplizna Thursday for use in patients with IgG4-related disease. Uplizna is the ...

Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in ...

The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund ...

The FDA has asked for another well-controlled trial to establish the efficacy of reproxalap in dry eye disease.

The European Medicines Agency asked for three clinical trials to be placed on hold until the exact cause of death of a US ...

The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1.

Roche’s reorganization of Spark Therapeutics is coming more into focus, with nearly 300 employees being let go by the end of ...

Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational ...

With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, ...

While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers ...

J&J and its subsidiary, Red River Talc, had proposed a $9 billion bankruptcy package to settle cancer claims linked to its ...

Already reeling from years of market chaos, the announced departure of CBER chief Peter Marks sent a ripple across biopharma ...