Browsing Tag
US Food and Drug Administration
333 posts
Amarin bags Vascepa FDA approval for reducing cardiovascular risk
Vascepa FDA approval : New Jersey-based Amarin has secured approval from the US Food and Drug Administration (FDA)…
Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma
Delaware-based pharma company Incyte has secured priority review for pemigatinib from the US Food and Drug Administration (FDA)…
Y-mAbs begins roll-out of BLA of naxitamab to FDA for neuroblastoma
US biopharma company Y-mAbs Therapeutics has submitted the first portions of its biologics license application (BLA) for naxitamab…
FDA approves ApiFix MID-C system for progressive AIS
Israeli medical devices manufacturer ApiFix has bagged approval from the US Food and Drug Administration (FDA) for marketing…
FDA clears Biobeat wearable watch and patch for BP measurement
Israeli biotech company Biobeat has secured a 510A clearance from the US Food and Drug Administration (FDA) for…
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…