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The advisory committee voted 6-7 against the finding of substantial evidence from adequate and well controlled studies that show that eteplirsen induces production of dystrophin to a level

These funds will be used to conduct clinical bridging studies to further assess the vaccine’s safety, immunogenicity and efficacy in populations different from the original testing region. Merck

US-based Ironwood Pharmaceuticals will pay AstraZeneca up to $265m for US rights to the drug, even though the UK firm will continue to manufacture Zurampic and provide other

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