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binx health receives EUA Authorizing at-Home COVID-19 Sample Collection by Universities, Employers americanpharmaceuticalreview
December 16, 2020
binx health has received an amendment to its COVID-19 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), this time for centralized specimen collection kit distribution and retrieval by large partners.
Iterum Therapeutics Submits NDA for Oral Sulopenem americanpharmaceuticalreview
December 16, 2020
Iterum Therapeutics has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a ...
US FDA report finds Moderna’s Covid-19 vaccine to have no specific safety concerns pharmaceutical-technology
December 16, 2020
The US Food and Drug Administration (FDA) in its briefing document stated that Moderna’s experimental Covid-19 vaccine, mRNA-1273, is 94.1% effective in preventing symptomatic Covid-19.
US FDA nod for Ocrevus (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive MS expresspharma
December 16, 2020
Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional Ocrevus dosing regimen.
Xentria gets US FDA orphan drug designation for XTMAB-16 in sarcoidosis expresspharma
December 16, 2020
Xentria announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its intravenous TNF-α inhibitor, XTMAB-16, for the treatment of sarcoidosis.
FDA grants Emergency Use Authorization for Pfizer’s COVID-19 vaccine BNT162b2 europeanpharmaceuticalreview
December 15, 2020
The US has approved emergency use of Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, in people 16 years of age and older.
FDA takes key action in fight against COVID-19 by issuing Emergency Use Authorization for first COVID-19 vaccine worldpharmanews
December 14, 2020
The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 ...
Albireo submits rare liver disease med odevixibat to FDA and EMA pharmatimes
December 14, 2020
Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).
Alembic Pharma gets USFDA final approval for Asenapine Sublingual Tablets expresspharma
December 14, 2020
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.
US FDA gives EUA for Pfizer/BioNTech COVID-19 vaccine expresspharma
December 14, 2020
The US Food and Drug Administration (USFDA) granted an emergency use authorisation for Pfizer and BioNTech’s COVID-19 vaccine which was shown to be 95 per cent effective in preventing the disease in a late-stage trial.

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