Browsing Tag
US Food and Drug Administration
348 posts
FDA approves G1 Therapeutics’ Cosela for reducing chemotherapy-induced bone marrow suppression
G1 Therapeutics has achieved a significant milestone with the recent U.S. Food and Drug Administration (FDA) approval of…
Targovax’s ONCOS-102 receives FDA fast track designation for malignant pleural mesothelioma treatment
In a significant development for cancer treatment, Targovax, a Norwegian biotech firm specializing in immune-oncology, has announced that…
FDA approves Opdivo and Cabometyx combo for advanced kidney cancer treatment
The U.S. Food and Drug Administration (FDA) has officially approved the combination of Bristol Myers Squibb’s Opdivo (nivolumab)…
ViiV Healthcare’s Cabenuva secures FDA approval for HIV treatment
ViiV Healthcare has received FDA approval for Cabenuva, a long-acting treatment regimen for HIV-1 infection in adult patients.…
Janssen Pharmaceutical’s DARZALEX FASPRO gains FDA approval for AL amyloidosis treatment
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj),…
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…