The FDA's approval is grounded in an evidence totality and comprehensive data package, which includes outcomes from a study.

Celltrion launches ADC cancer drug trials in U.S. while planning additional INDs Celltrion accelerates its global drug ...

Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, ...

Celltrions Vegzelma becomes Europes top prescribed anticancer drug in two years Celltrions cancer treatment Vegzelma achieves impressive market dominance in Europe within two years ...

As Sandoz gears up to launch one of the most anticipated biosimilars of the year, the company could face near-term ...

The US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra, developed by South ...

US biotech major Amgen =announced that it has reached resolution of its patent infringement litigation related to South Korea ...

SEOUL, Feb. 7 (Yonhap) -- Seoul shares fell marginally late Friday morning as investors took profit following three consecutive sessions of gains this week. The benchmark Korea Composite Stock Price ...

Celltrion announced on Friday that its biosimilar Avtozma, a version of the autoimmune disease treatment Actemra (active ingredient tocilizumab), has received product approval from the US Food and ...

SEOUL, Feb. 7 (Yonhap) -- Seoul shares opened slightly lower Friday, as investors unloaded large caps after three consecutive sessions of gains this week. The benchmark Korea Composite Stock Price ...

The U.S. Food and Drug Administration (FDA) has approved Celltrion’s AVTOZMA (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA.