Browsing Tag
US FDA
379 posts
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…
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…
Avrobio gets FDA orphan status for AVR-RD-02 in Gaucher disease
US gene therapy company Avrobio has secured orphan-drug designation for AVR-RD-02, its investigational gene therapy, for the treatment…
Janssen bags Stelara FDA approval for ulcerative colitis treatment
Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged…
Alexion Pharmaceuticals bags Ultomiris FDA approval for atypical HUS
Ultomiris FDA approval : Alexion Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for…
Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne
AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and…