Food and Drug Administration (FDA)
NEWS
The company sent the medication to a Florida neurology clinic free of charge.
BioLabs is opening its next hub in Dallas in a 37,000-square-foot flexible life science facility. The Biotech+ Hub can accommodate 35 startups, for which it’s now accepting applications.
ZN-c3 is a WEE1 inhibitor that could be used as monotherapy for uterine serous carcinoma and solid tumors, as well as combination therapy for ovarian cancer, alongside chemotherapy.
FDA greenlit Janssen’s Invega Hafyera, the first long-acting antipsychotic drug of its kind that provides six months’ control of symptoms with a single dose.
Mesoblast shares dropped on the last day of August 2021 after it was told that its candidate COVID-19 treatment needs to undergo another trial to be green-lit for emergency approval by the FDA.
The company announced it paused the screening and dosing of an investigational gene therapy for patients with XLMTM following a serious adverse event report in a trial participant.
Marion Gruber, director of the agency’s Office of Vaccines Research & Review is leaving at the end of October. Phil Krause, OVRR’s deputy director, is exiting in November.
Gilead won the most recent battle when a U.S. appeals court threw out a $1.2 billion ruling against the company.
The combined company out of the Humacyte SPAC will be called Humacyte and is expected to trade shares of common stock and warrants on the Nasdaq Global Select Market.
JOBS
IN THE PRESS