Browsing Tag
US Food and Drug Administration
348 posts
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…
Deciphera gets Qinlock FDA approval for fourth-line advanced GIST
Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA)…
No drops, no plugs: How the iTEAR100 device triggers tears in 30 seconds
Olympic Ophthalmics secures FDA clearance for iTEAR100, a handheld neurostimulator that activates tear production in seconds. Find out how it could transform dry eye treatment.
FDA rejects Blueprint’s NDA for AYVAKIT for treatment of fourth-line GIST
Blueprint Medicines said that the US Food and Drug Administration (FDA) has rejected its new drug application (NDA)…
Abbott gets FDA EUA for COVID-19 antibody blood test on Alinity i system
Abbott has been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its…
Selpercatinib FDA approval : Lilly’s therapy approved for treatment of lung and thyroid cancers with RET alteration
Selpercatinib FDA approval : The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Retevmo…