Browsing Tag
US FDA
379 posts
Sparta’s SBM-01 Biomimetic Implant gets FDA breakthrough device status
Sparta Biomedical said that its SBM-01 Biomimetic Implant has secured a breakthrough device designation from the US Food…
Ambrx’s ARX788 gets FDA orphan drug status for gastric cancer treatment
Ambrx has announced that its antibody drug conjugate (ADC) ARX788 has been granted orphan drug designation by the…
Caplin Point Laboratories gets FDA approval for Prochlorperazine Edisylate Injection
Caplin Point Laboratories said that its subsidiary Caplin Steriles has secured final approval from the US Food and…
Transcenta gets US FDA clearance for launching phase 1 trial of TST005
Transcenta has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug…
FDA grants emergency use authorization to Janssen COVID-19 vaccine
The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the Janssen COVID-19…
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)…
Biocon launches generic Tacrolimus in U.S.: A gamechanger in transplant care
Find out how Biocon’s launch of generic Tacrolimus in the U.S. marks a strategic leap in affordable transplant care and global generic market expansion.
Lilly secures $375m deal with US govt for bamlanivimab Covid-19 treatment
Eli Lilly and Company (Lilly), a global pharmaceutical leader, has signed a significant $375 million agreement with the…
AstraZeneca resumes AZD1222 Covid-19 vaccine trials after safety review
AstraZeneca has announced the resumption of its clinical trials for the AZD1222 Covid-19 vaccine candidate in multiple countries,…
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…