Browsing Tag
FDA
293 posts
Lilly begins real-world Covid-19 study of bamlanivimab in New Mexico to assess outcomes in high-risk patients
Eli Lilly begins a real-world Covid-19 study of bamlanivimab in New Mexico. Find out how mobile clinics aim to reduce hospitalizations in high-risk patients.
Alligator Bioscience’s mitazalimab gets FDA approval for clinical trials in US
Swedish biotech company Alligator Bioscience has announced that the US Food and Drug Administration (FDA) has approved its…
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…