Browsing Tag
FDA
341 posts
Lilly partners with UnitedHealth Group for pragmatic study of bamlanivimab in high-risk COVID-19 patients
Eli Lilly and Company (Lilly) has formed a strategic collaboration with UnitedHealth Group to conduct a pragmatic clinical…
Ensemble Orthopedics secures FDA clearance for innovative CMC implant for osteoarthritis treatment
Ensemble Orthopedics, a Texas-based medical device company, has secured 510(k) clearance from the US Food and Drug Administration…
Novo Nordisk secures FDA approval for Saxenda label update targeting adolescent obesity treatment
Novo Nordisk, a global leader in diabetes and obesity care, has received approval from the US Food and…
Protalix BioTherapeutics receives FDA extension for pegunigalsidase alfa review: What this means for Fabry disease treatment
Protalix BioTherapeutics, a leader in the development of innovative therapies for rare diseases, has announced a significant update…
FDA accepts SB11 BLA for review: A step towards affordable treatment for retinal vascular disorders
The United States Food and Drug Administration (FDA) has recently accepted the biologics license application (BLA) for SB11,…
BRILINTA FDA approval: A major step in reducing stroke risks in acute ischemic stroke and high-risk TIA patients
AstraZeneca has secured U.S. Food and Drug Administration (FDA) approval for BRILINTA (ticagrelor), expanding its use to reduce…
Remdesivir FDA approval: A milestone in the fight against COVID-19
In a significant development for the medical and pharmaceutical communities, Gilead Sciences, a California-based biopharmaceutical company, has received…
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…
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…