Browsing Tag
US Food and Drug Administration
333 posts
AstraZeneca wins FDA approval for Tagrisso in adjuvant treatment of early-stage NSCLC patients with EGFR mutations
Find out how AstraZeneca’s expanded FDA approval for Tagrisso is transforming early-stage lung cancer treatment standards.
FDA grants emergency use authorization for Moderna’s Covid-19 vaccine: What this means for the U.S. pandemic response
Find out how Moderna’s mRNA-1273 vaccine received FDA emergency use authorization and what it means for the United States’ Covid-19 vaccination rollout.
Pfizer and BioNTech’s COVID-19 vaccine secures FDA emergency use authorization
In a groundbreaking move, Pfizer and BioNTech have received emergency use authorization (EUA) from the US Food and…
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…
Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate
Merck & Co., a global leader in pharmaceutical development, has submitted applications to the US Food and Drug…
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,…