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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.
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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.
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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.
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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.
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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 ...
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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).
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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.
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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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FDA set to review GSK’s Nucala for nasal polyps
pharmatimes
December 11, 2020
The US Food and Drug Administration (FDA) is set to review GlaxoSmithKline’s (GSK) Nucala, after accepting a regulatory submission seeking approval for its use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
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FDA Approves First Drug to Treat Rare Metabolic Disorder
americanpharmaceuticalreview
December 11, 2020
The U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder.