June 15, 2021
June 15, 2021 – The U.S. FDA has approved a new indication for Pradaxa® (dabigatran etexilate), manufactured by Boehringer Ingelheim, to treat children at least
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Global Reach Health News
June 15, 2021
June 15, 2021 – The U.S. FDA has approved StrataGraft® (allogeneic cultured keratinocytes and dermal
fibroblasts in murine collagen-dsat), manufactured by Mallinckrodt, to treat adults
June 14, 2021
June 14, 2021 – The U.S. FDA has approved expanded indications for Epclusa® (sofosbuvir/velpatasvir –
Gilead) and Mavyret® (glecaprevir/pibrentasvir
June 11, 2021
June 11, 2021 – Viona Pharmaceuticals, Inc., has recalled two lots of Metformin Hydrochloride Extended-
Release Tablets, USP 750mg due to the detection of N-nitrosodimethylamine
June 10, 2021
June 10, 2021 – The U.S. FDA has approved an expanded indication for Trikafta® (elexacaftor/tezacaftor/
ivacaftor), manufactured by Vertex Pharmaceuticals. The drug is now indicated
June 10, 2021
June 10, 2021 – The U.S. FDA has authorized an extension to the shelf life for Johnson & Johnson’s (J&J)
COVID-19 vaccine, manufactured by J&J subsidiary Janssen
June 8, 2021
June 8, 2021 – The U.S. FDA has granted accelerated approval to Prevnar 20TM (pneumococcal 20-valent
conjugate vaccine), manufactured by Pfizer, for use in adults to prevent invasive
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