Spruce Biosciences has put out new shoots, snapping up rights to a former BioMarin rare disease candidate and outlining plans ...

Ipsen and its fellow French partner Genfit are competing with Intercept and Advanz’s Ocaliva, which was approved in 2016 and ...

Seek regulatory approval and maximize the U.S. commercial potential of TA-ERT for the treatment of MPS IIIB. Spruce intends to seek U.S. accelerated approval of TA-ERT for MPS IIIB based on ...

which did not meet the requirements of the FDA Accelerated Approval regulations. Price Action: GSK stock is up 1.74% at $35.99 at the last check Thursday.

The drug's accelerated approval looked like it could be in jeopardy however, after a confirmatory trial failed to show that it was able to help patients live longer than best supportive care.

This is an accelerated approval based on tumour response rate and durability of response data and must be verified by further data from larger trials. This is the second time that Keytruda has ...

potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the biologics license application (BLA), and other opportunities to expedite ...

including ongoing work to provide the FDA with support for the potential use of the accelerated approval pathway for SORD Deficiency. Financial Results About Applied Therapeutics Applied ...

potentially leading to accelerated approval of contracts, lower taxes, and government funding support/incentives to promote shipyard investments. For Huntington Ingalls, the largest military ...