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The Phase 1 study is being performed in asymptomatic "high excreter" (ASHE) patients, who carry the genetic mutation of acute intermittent porphyria (AIP) and have elevated levels of

The product line provides a full assortment of hospital-quality products for consumers categorized as Advanced Wound Care, First Aid, Personal Care, and Home Healthcare which help provide comfort

Andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein specifically designed to reverse the anticoagulant activity of Factor Xa inhibitors. Portola is

This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia. ARIAD president of research and development and chief scientific officer Timothy

The company is seeking approval depending on the Reprieve clinical study results, which determined the long-term maintenance of efficacy and safety of Fanapt antipsychotic agent. The agency is

The MAA for GRASPA, ERYTECH’s lead product, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the pivotal GRASPALL 2009-06 Phase 2/3

There is no set expiration date for the program. The Company intends to use cash on hand, cash generated from operations, existing credit facilities or other financing to

Chiltern now comprises 3,700 people across 47 countries, expanding Chiltern’s footprint in Europe, North America and Asia-Pacific. The acquisition enhances Chiltern’s oncology, biopharma and source offerings, broadens its

The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality