Government
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.
Two months after he was stepped down from the role of chief executive officer of Legend Biotech, Fangliang “Frank” Zhang has been arrested for smuggling genetic resources from the People’s Republic of China.
The U.S. FDA approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
Eiger’s Zokinvy is the first-ever approved treatment for children with Huchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.
Late Friday, the FDA gave the green light to Regeneron’s REGN-COV2, a combination of casirivimab and imdevimab.
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
With limited doses currently available, the logistics of inoculation are in the works and will certainly require guidance from the outgoing and incoming administrations of Donald Trump and Joe Biden, respectively.
The U.S. FDA has lifted a clinical hold on Cellectis’ Phase I MELANI-01 trial evaluating multiple myeloma candidate UCARTCS1 just months after working with the French biopharmaceutical company to adjust its trial protocol to enhance patient safety.
The U.S. Food and Drug Administration has four distinct approaches to speeding the drug approval process. Several of today’s announcements had one or more of these designations.
With Pfizer and Moderna lining up their COVID-19 vaccine candidates for EUA, the U.S. FDA announced it will make publicly available all data and information that will be used to consider authorization of vaccines and therapeutics against the virus.
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