Browsing Tag
US Food and Drug Administration
348 posts
Gilead Sciences bags Descovy FDA approval for prevention of HIV infection
Descovy FDA approval : Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) has…
Global Blood Therapeutics bags Oxbryta FDA approval for sickle cell disease
Oxbryta FDA approval : Global Blood Therapeutics (GBT), a California-based biopharma company, has bagged approval for Oxbryta (voxelotor)…
Usona Institute gets FDA breakthrough status for psilocybin in MDD
Wisconsin-based Usona Institute has been granted breakthrough therapy designation for psilocybin from the US Food and Drug Administration…
SK Biopharmaceuticals bags XCOPRI FDA approval for partial-onset seizures
XCOPRI FDA approval : SK Biopharmaceuticals said that its US subsidiary SK Life Science has been granted approval from…
Carestream’s digital imaging technologies get FDA approval
Carestream’s Dual Energy imaging technology and also its Focus 35C Detector with Image Suite Software have secured 510…
Levo gets FDA fast track status for LV-101 in Prader-Willi syndrome
US biotech company Levo Therapeutics has been granted fast track designation for LV-101 (intranasal carbetocin) from the US…
CooperVision MiSight contact lens gets FDA approval to slow down myopia in children
Soft contact lens manufacturer CooperVision has secured approval for its MiSight contact lens from the US Food and…
Novartis bags Adakveo FDA approval to reduce VOCs in sickle cell disease
Adakveo FDA approval : Swiss drugmaker Novartis has bagged approval for Adakveo (crizanlizumab-tmca) from the US Food and…
F2G gets olorofim breakthrough therapy status from FDA for mold infections
F2G has secured breakthrough therapy designation to olorofim (formerly F901318) from the US Food and Drug Administration (FDA)Â …
Celgene, Acceleron bag Reblozyl FDA approval for anemia in beta thalassemia
Reblozyl FDA approval : Celgene and Acceleron Pharma have bagged approval from the US Food and Drug Administration…