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The regulator has accepted the firm’s new drug application (NDA) for the accelerated approval of tazemetostat to treat patients with relapsed or refractory FL who have secured at

This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 17, 2020. “There remains a critical need for additional therapies in large B-cell

Tecentriq is a monoclonal antibody designed to bind with PD-L1 protein that is expressed on tumour cells and tumour-infiltrating immune cells, restricting its interactions with both PD-1 and

Vivo Capital was the lead investor with other new investors including funds managed by Logos Capital, Janus Henderson, Foresite Capital, Cormorant Asset Management, BVF Partners, and investor HBM

The FDA granted Priority Review for the NDA, which provides for a six-month review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August

Keytruda plus chemotherapy achieved one of its dual primary endpoints of PFS in patients with mTNBC whose tumours expressed PD-L1. Keytruda, an anti-PD-1 therapy, works by blocking the

As per the new drug application (NDA) that has been accepted by the FDA, Novartis is seeking approval for the use of capmatinib as a treatment for first-line

The business comprises of a portfolio of 62 brands in multiple therapy areas such as Respiratory, Neurology, VMS, Dermatology, Gastroenterology, Pain and Vaccines, which would transfer to Dr.