Browsing Tag
US FDA
379 posts
Bracco Diagnostics secures FDA approval for new CardioGen-82 infusion system: A major advancement in cardiac PET imaging
Bracco Diagnostics, a leading US subsidiary of the renowned Italian diagnostic imaging company Bracco Imaging, has officially received…
Regeneron Pharmaceuticals’ Inmazeb FDA approval: A milestone in Ebola treatment
Regeneron Pharmaceuticals has achieved a significant breakthrough with the approval of its antibody cocktail, Inmazeb (atoltivimab, maftivimab, and…
AstraZeneca’s Farxiga receives FDA breakthrough therapy designation for chronic kidney disease treatment
AstraZeneca’s Farxiga (dapagliflozin), a leading drug in the management of chronic kidney disease (CKD), has been granted Breakthrough…
FDA approves Opdivo and Yervoy combination for malignant pleural mesothelioma treatment
Bristol Myers Squibb (BMS) has secured approval from the US Food and Drug Administration (FDA) for a new…
Gan & Lee gets FDA orphan drug status for GLR2007 in malignant glioma
Gan & Lee Pharmaceuticals has been given orphan drug designation from the US Food and Drug Administration (FDA)…
KA Imaging gets FDA clearance for Reveal X-ray detector
KA Imaging said that Reveal, its portable dual-energy X-ray detector has been granted 510(k) clearance from the US…
FDA accepts Ascendis Pharma’s TransCon hGH BLA for pediatric GHD
Ascendis Pharma, a Danish biopharma company, said that the US Food and Drug Administration (FDA) has accepted its…
Rocket Pharmaceuticals gets FDA fast track status for RP-L401 in infantile malignant osteopetrosis
Rocket Pharmaceuticals has secured fast track designation for RP-L401 gene therapy candidate from the US Food and Drug…
Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma
DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have…
Kazia Therapeutics gets fast track status for paxalisib in glioblastoma
Kazia Therapeutics, an Australian oncology company, has secured fast track designation (FTD) from the US Food and Drug…