Government
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Moderna announced that it plans to submit its request to the U.S. Food and Drug Administration for an Emergency Use Authorization for its COVID-19 vaccine, mRNA-1273.
The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
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.
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