US FDA authorizes Moderna Covid-19 vaccine mRNA-1273

US FDA authorizes Moderna Covid-19 vaccine mRNA-1273

Moderna Covid-19 vaccine : The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for mRNA-1273, the messenger RNA (mRNA) Covid-19 vaccine candidate of Moderna. The FDA authorization is for the use of mRNA-1273 in individuals aged 18 years and more for the prevention of Covid-19 caused by severe acute respiratory syndrome […]

Gilead Sciences bags Remdesivir FDA approval for Covid-19 treatment

Gilead Sciences bags Remdesivir FDA approval for Covid-19 treatment

Remdesivir FDA approval : Gilead Sciences, a California-based biopharma company, has bagged approval from the US Food and Drug Administration (FDA) for its antiviral drug Veklury (remdesivir) for Covid-19 treatment in patients requiring hospitalization. This makes remdesivir the first approved treatment for coronavirus in the US. Remdesivir FDA approved indication : Veklury has been approved […]

Regeneron bags Inmazeb FDA approval for treatment of Ebola

Regeneron bags Inmazeb FDA approval for treatment of Ebola

Inmazeb FDA approval : Regeneron Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus (Ebola virus). Formerly known as REGN-EB3, Inmazeb is now the first drug regimen to get FDA approval for Ebola treatment, covering adult and […]

Second EUA issued by FDA to decontaminate N95 respirators for reuse

Second EUA issued by FDA to decontaminate N95 respirators for reuse

The US Food and Drug Administration (FDA) has granted the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The regulator said that the EUA will support decontamination of nearly 750,000 N95 respirators per day in the country. The emergency use authorization has […]

Cerovene bags FDA approval for Daraprim generic for toxoplasmosis treatment

Cerovene bags FDA approval for Daraprim generic for toxoplasmosis treatment

Cerovene has bagged approval from the US Food and Drug Administration (FDA) for its generic version of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis when used with a sulfonamide, a group of medicines for bacterial infections. Toxoplasmosis is a foodborne infection caused by the parasite Toxoplasma gondii. A severe form of the condition can […]