FDA grants Priority Review of Astellas’ zolbetuximab BLA

Astellas Pharma Inc has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review of its zolbetuximab Biologics License Application

Novartis buys Pharming priority review voucher for a song

Pharming has agreed a deal to sell a recently awarded priority review voucher (PRV) to Novartis for around $21 million - well below the market rate.

FDA sets Feb review date for Trodelvy in new breast cancer u...

Gilead Sciences will hear back from the FDA in February next year about its marketing application for Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer, billed b

Incyte makes bid to join the checkpoint inhibitor club

Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and HIV infections.

FDA sets August action date for Seattle’s oral HER2 drug tuc...

Gilead closes in on second CAR-T approval in US