Browsing Tag
US Food and Drug Administration
333 posts
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…
Ultragenyx Pharmaceutical, Kyowa Kirin bag Crysvita FDA approval for TIO
Crysvita FDA approval for TIO : Ultragenyx Pharmaceutical and Kyowa Kirin have secured approval for their recombinant fully…
Polycythemia vera treatment : Protagonist Therapeutics’ PTG-300 gets FDA ODD
Protagonist Therapeutics has bagged the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for…
Leap Therapeutics gets FDA orphan status for DKN-01 for gastric and gastroesophageal junction cancer
US immuno-oncology company Leap Therapeutics has been granted orphan drug designation for DKN-01 from the US Food and…
Cipla gets FDA’s final approval for generic version of Migranal with CGT designation
Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL…
Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19
Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra…