Browsing Tag
US FDA
379 posts
Allergan bags Ubrelvy FDA approval for migraine treatment
Ubrelvy FDA approval : Irish pharma company Allergan has bagged approval from the US Food and Drug Administration…
FDA rejects Correvio Pharma’s anti-arrhythmic drug Brinavess
Correvio Pharma said that the US Food and Drug Administration (FDA) decided not to approve its anti-arrhythmic drug…
Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798
Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics…
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)…
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…
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)…
Ferring, Blackstone invest $570m in nadofaragene firadenovec gene therapy
Ferring Pharmaceuticals, a Swiss specialty biopharmaceutical group, has teamed up with private investment platform Blackstone Life Sciences to…
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…