The positive opinion includes important survival data from the AZA-001 trial in higher-risk myelodysplastic syndromes (MDS) patients. The Committee for Medicinal Products for Human Use (CHMP), which reviews
This FDA approval represents the first for a bronchial valve implant for the lungs. The FDA humanitarian device exemption (HDE) approval of the IBV valve system is based
In the study, oritavancin activity at 10, 50 and 100mg/kg/day and a pegylated (PEG400) formulation of oritavancin at 100mg/kg/day were compared to vancomycin activity at 50mg/kg/day against clindamycin-induced
The open-label trial met both its primary (efficacy) and secondary (safety) endpoints. All doses of radezolid were as efficacious as linezolid and demonstrated a good safety profile. The
According to the company, the Vitros 5600 integrated system is designed to integrate clinical chemistry and immunoassay testing to increase laboratory productivity and will be able to perform
The difference between treatment arms may have been related to the 16% discontinuation rate in the Reyataz/r arm and the 21% discontinuation rate in the lopinavir/r arm, the
The Committee for Medicinal Products for Human Use (CHMP) received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies
The research confirmed, at the genomic level, that the immune system response to the virus, and not the virus by itself, results in common cold symptoms. Data generated
Astellas’s European subsidiary, Astellas Pharma Europe BV, previously submitted the marketing authorization application (MAA) for telavancin for complicated skin and soft tissue infections (cSSTI) in adults to the
The new data indicate that patients who continued to receive denufosol for an additional 24 weeks during the open-label extension experienced a progressive improvement in forced expiratory volume
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