Browsing Tag
US Food and Drug Administration
333 posts
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) …
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…
Cellectis begins MELANI-01 clinical trial for UCARTCS1 in multiple myeloma
Cellectis said that it has dosed the first patient in a phase 1 study – the MELANI-01 clinical…
Mirum gets FDA breakthrough therapy status for maralixibat for Alagille syndrome
Mirum Pharmaceuticals has secured the breakthrough therapy designation for maralixibat from the US Food and Drug Administration (FDA)…
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…