Approvals
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.
The White House has also called for an independent investigation and more information from China about the pandemic’s origins.
AbbVie is aiming Skyrizi and Rinvoq at various indications to augment expected declines in the use of its $20-billion-generating-powerhouse Humira, which will lose patent protection in 2023.
NGM Bio’s aldafermin failed to hit its primary endpoint in its Phase IIB trial because of that, the company decides to shift resources to other programs.
It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.
If approved, Takeda said Maribavir would become the first and only treatment indicated for CMV infection in refractory patients.
Janux plans to use the funds raised from the IPO to submit four Investigational New Drug applications to the U.S. FDA in the first half of 2022.
CARsgen is building a new $157 million CAR-T manufacturing facility in Durham, that is expected to create approximately 200 new jobs.
Maria Fardis, who has been with the company since 2016, stepped down as CEO following FDA’s delay on its Biologics License Application.
Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.
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