Browsing Tag
US Food and Drug Administration
348 posts
Bayer gets Lampit FDA approval for Chagas disease in pediatric patients
Lampit FDA approval : Bayer has bagged approval for its antiprotozoal medication Lampit (nifurtimox) from the US Food…
Ascentage Pharma gets FDA ODD for APG-2575 in Waldenström macroglobulinemia
Ascentage Pharma has been granted orphan drug designation (ODD) for its Bcl-2 inhibitor APG-2575 from the US Food…
CenterLab’s anti-diabetic drug candidate CS02 meets primary endpoint in phase 2 trial
Taiwanese pharma company Center Laboratories (CenterLab) said that its anti-diabetic drug candidate CS02 has met the primary endpoint…
ViiV Healthcare bags Rukobia FDA approval for HIV patients with limited treatment options
Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia…
Celltex Therapeutics gets FDA nod for Covid-19 stem cell clinical trial
Covid-19 stem cell clinical trial : Celltex Therapeutics has been given the clearance by the US Food and…
Masimo gets FDA clearance for Centroid patient monitoring sensor
Masimo, a US medical device company, has received clearance from the US Food and Drug Administration (FDA) for…
Zogenix bags Fintepla FDA approval for Dravet syndrome treatment
Fintepla FDA approval : Zogenix has bagged approval from the US Food and Drug Administration (FDA) for Fintepla…
Reneo Pharmaceuticals gets FDA ODD for REN001 in primary mitochondrial myopathies
Reneo Pharmaceuticals has been granted the orphan drug designation (ODD) for its lead drug candidate REN001 from the…
Roche gets FDA nod for cobas EZH2 Mutation Test as companion diagnostic for follicular lymphoma patients
Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas EZH2 Mutation Test…
Mylan gets favorable court decision in Biogen’s Tecfidera patent case
Dutch generic drugmaker Mylan said that the US District Court for the Northern District of West Virginia has…