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TG-1101 is a highly potent next generation glycoengineered anti-CD20 monoclonal antibody to ibrutinib monotherapy in high risk CLL. The multicenter GENUINE trial, which evaluated the efficacy and safety of

Ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action. A meeting with the FDA to discuss these data and to agree

The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival (“OS”), in the intention-to-treat (ITT) population of patients treated

The UK's Competition and Markets Authority (CMA) said both the firms entered into agreements under which Actavis UK incentivised Concordia not to enter the market with its own

Under the deal, the companies will jointly develop and commercialise MEDI8897, a highly potent monoclonal antibody (mAb) that neutralises RSV by binding the RSV fusion (F) protein expressed on

Ocaliva has been conditionally approved in the European Union for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate

Ataluren was generally well tolerated and ACT CF confirmed a favorable safety profile for ataluren, which has now been used by more than 1,000 patients across multiple indications.

The study demonstrated that the combination of Perjeta (pertuzumab), Herceptin  (trastuzumab) and chemotherapy (the Perjeta-based regimen) reduced risk of recurrence of invasive disease or death (invasive disease-free survival) in people

The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the NDA submission