June 7, 2021
June 7, 2021 – The U.S. FDA has updated the prescribing information for raxibacumab, manufactured by
Emergent BioSolutions, to include a black box warning for risk
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News
June 7, 2021
June 7, 2021 – The U.S. FDA has approved an expanded indication for Ultomiris® (ravulizumab-cwvz),
manufactured by Alexion Pharmaceuticals
June 7, 2021
June 7, 2021 – The U.S. FDA has granted accelerated approval to AduhelmTM (aducanumab), manufactured
by Biogen, to treat Alzheimer’s disease
June 4, 2021
June 4, 2021 – The U.S. FDA has approved expanded indications for Merck Sharp & Dohme Corp’s Noxafil®
(posaconazole) intravenous (IV) injection and Noxafil delayed-release
June 4, 2021
June 4, 2021 – The U.S. FDA has updated the emergency use authorization (EUA) for Regeneron’s REGEN-
COVTM (casirivimab/imdevimab), a combination monoclonal antibody
June 4, 2021
June 4, 2021 – The U.S. FDA has approved WegovyTM (semaglutide), manufactured by Novo Nordisk, as an adjunct to diet and exercise for chronic weight management in adults
June 4, 2021
June 4, 2021 – The U.S. FDA has approved Tembexa® (brincidofovir), manufactured by Chimerix, to treat
smallpox. Although naturally occurring smallpox has been eradicated since 1980
June 4, 2021
June 4, 2021 – The U.S. FDA has approved Ryplazim® (plasminogen, human-tvmh), manufactured by
Liminal BioSciences, to treat plasminogen deficiency type 1 (hypoplasminogenemia)