Food and Drug Administration (FDA)
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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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 24, 2020.
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.
The U.S. Food and Drug Administration has accepted ADC Therapeutics’ Biologics License Application (BLA) and granted priority review for the company’s relapsed/refractory diffuse large B-cell lymphoma (DLBCL) treatment, loncastuximab tesirine (Lonca).
The World Health Organization (WHO) recommends against using Gilead Sciences’ remdesivir as a treatment for COVID-19.
As expected after Pfizer and BioNTech announced their COVID-19 vaccine Phase III trial had completed and demonstrated a 95% efficacy rate, the companies plan to apply for an Emergency Use Authorization (EUA) with the FDA.
The EUA for the combination of Olumiant and Remdesivir marks the first combination for COVID-19 greenlit in the U.S.
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.
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