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BT-061 is a humanized monoclonal antibody that works by activating the body’s T-regulatory cells, a subset of T-cells, strengthening a natural function of the body that prevents excessive

Earlier, following its inspection in March, the FDA issued a list of observed deviations from current Good Manufacturing Practice (GMP). In return, the company responded to the FDA’s

The lawsuit was filed in connection with Sun Pharma‘s submission of abbreviated new drug application (ANDA) seeking marketing rights for the generic versions of Depomed‘s 500mg and 1000mg

Exco’s eDiary will allow patients to participate in the trial irrespective of their location, age or proximity to the site. The study, which will focus on new research

The EU marketing authorization of BYDUREON is based on review of the submission package, including data from studies in the DURATION clinical program in which exenatide resulted in

The Phase 2 randomized, double-blind, placebo-controlled trial will recruit around 80 patinets. The study is designed to assess the efficacy, safety and tolerability of RP-G28 to treat the

Lonza said the new development and manufacturing services are available for both mammalian and microbial applications. Lonza is offering Light Path to customers from all five of its

Levofloxacin oral solution 25mg/mL is the generic for McNeil Pharmaceutical’s Levaquin oral solution. The solution is indicated for the treatment of adults with mild, moderate and severe infections.

Defibrotide is an investigational drug indicated to treat and prevent veno-occlusive disease (VOD). As part of the agreement, Medison will manage the named-patient sales program, local registration, authorization,