Moderna announces vaccine efficacy of 94.1 per cent, to file for EUA with US FDA
Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of…
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US FDA
Unichem gets US FDA approval for Atenolol and Chlorthalidone Tablets
They are indicated for the treatment of hypertension, to lower blood pressure
Lupin launches Tacrolimus Capsules USP
They are indicated for the prophylaxis of organ rejection in combination with other immunosuppressants
US FDA grants EUA to monoclonal antibodies from Regeneron for COVID-19 treatment
In a clinical trial, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalisation or…
Pfizer applies to US FDA for EUA of its COVID-19 vaccine
The US FDA said that it would hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine
Glenmark Pharma gets ANDA approval for Tacrolimus Capsules
It is the generic version of Prograf Capsules of Astellas Pharm
AbCellera antibody gets US FDA EUA as monotherapy for COVID-19 treatment
AbCellera’s partner, Eli Lilly and Company, will supply the US government with 300,000 doses of bamlanivimab for allocation to…
Lupin’s Somerset facility gets 13 observations post US FDA inspection
The company does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of…
J&J to test COVID-19 vaccine in youths aged 12-18
Depending on safety and other factors, the company plans to test in even younger children afterwards
Zydus Cadila gets tentative US FDA approval for Dapagliflozin Tablets
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to improve glycemic control in adults with type 2…