This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib ... the final label with the FDA.

AstraZeneca and partner Merck & Co look set to have a much narrower label ... The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted by 11 to one that Lynparza (olaparib) should be ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a ...

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...

Patients in the pembrolizumab-olaparib arm had clinically meaningful improvements in PFS over patients in the control arm.

The US Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for ...

The sector has seen billions in merger and acquisition activity in recent years; a September 2024 analysis by Insight ...

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab). The regulatory body approved Opdivo plus Yervoy as a ...

Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK ...

The FDA has accepted for review a resubmission of the BLA for bevacizumab-vikg (ONS-5010) for the treatment of wet AMD.