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The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety

The Phase 2a study will assess the safety of BPX-01 in 30 patients randomized to 30 days of treatment with either BPX-01 or a placebo. The endpoints of

The spacious, new facility – at 1,300 square meters in size – allows for the storage and distribution of a wide range of clinical trial materials with special

Descovy is indicated in the European Union (EU) to treat adults and adolescents aged 12 years and older with body weight at least 35 kg in combination with

The company plans to add 322,000ft² of manufacturing space to the current facility, nearly doubling its existing size. The construction, commissioning and validation of the facility expansion and

The regulator’s decision was based on results of CheckMate-141, a phase 3, open-label, randomized trial testing of Opdivo in comparison to three of the most commonly used treatments

Immunicum CEO Jamal El-Mosleh said: "We are pleased with the positive news from the Chinese Patent Office, SIPO, which will further strengthen the protection for our main product.

The JV will invest in a new company to be called Imutex. It will boost hVIVO’s commercial flu portfolio and expand its operations into mosquito-borne diseases, with the

The agency’s specific action date is not provided but is expected to happen before the end of this year. Lundbeck received a complete response letter in October 2014