Food and Drug Administration (FDA)
NEWS
Three weeks after snagging approval in the UK, the U.S. FDA approved Samsung Bioepis and Biogen’s biosimilar drug. Byooviz is the first Lucentis copycat biologic to hit the market.
From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.
COVID-19 remains relentless in challenging the community as it continues to evolve. Here are some of the top news for the week.
The FDA’s IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
The FDA awarded a number of designations for Takeda’s candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15.
FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here’s a look.
Brukinsa was approved for MSL patients who have received at least one anti-CD20-based regimen.
BeiGene plans to describe the power of its lung cancer portfolio at the European Society for Medical Oncology Congress 2021. The conference will run from September 16-21.
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