Food and Drug Administration (FDA)

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FDA
CARsgen is building a new $157 million CAR-T manufacturing facility in Durham, that is expected to create approximately 200 new jobs.
FDA
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.
Eli Lilly’s SURPASS-4 trial program shows tirzepatide, significantly reduced blood glucose levels and body weight better than insulin glargine in adult patients with type 2 diabetes.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
Shares of Voyager Therapeutics fell in aftermarket trading after its CEO and CMO announced plans to depart the company following clinical setbacks with a Parkinson’s disease program.
Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.
Thermo Fisher and the University of California partnered with the development and manufacturing of cell-based therapies with the construction of its 44,000 sq. ft. manufacturing facility.
FDA
X-Vax Technology is ready to submit an IND application to the U.S. FDA for its experimental herpes vaccine against HSV-1 and -2. Here’s what you need to know.
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