BIOPHARMA DIVE

Dive Brief: Gilead can manufacture supplies of its cancer cell therapy Yescarta from a new factory in Maryland, after the Food and Drug...

The Food and Drug Administration has appointed a new vaccine review head, naming the top scientist at a global public health non-profit to...

Dive Brief: Generic drug manufacturer Akorn on Thursday disclosed receipt from the Food and Drug Administration of a Form 483 inspection form...

Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the...

The Food and Drug Administration on Thursday approved a new hemophilia therapy that has the potential to be a more convenient option for some...

Philadelphia-based gene editing startup iECURE has raised $65 million in additional Series A venture funding, the company announced...

Mainstreaming cell and gene therapy clinical trials Cell and gene therapies (CGT) are starting to live up to their promise, not only to create...

The Food and Drug Administration has started the first regulatory review of a gene therapy for Duchenne muscular dystrophy, the treatment’s...

The Food and Drug Administration’s main office for reviewing new medicines cleared 37 in 2022, closing out the year with approvals of treatments...

Dive Brief: For the first time, supplies of a drug have run short in the U.S. as a result of problems tied to the spread of the new coronavirus,...