Approvals
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.
Two of Merck’s Phase III pediatric trials show 15-valent pneumococcal conjugate vaccine, V114, may be safe and effective in healthy children.
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.
PRESS RELEASES