New Biosimilars First Generic Drug Launches Oct. 25, 2024 - sulopenem etzadroxil and probenecid (Orlynvah) The FDA has approved Iterum’s Orlynvah for the treatment of uncomplicated urinary tract...

FDA approved BiTEs: Brand name Generic name Route Target Indication First FDA indication approval date Blincyto Blinatumomab IV anti-CD19 / anti-CD3 Acute lymphocytic leukemia 12/3/2014 Columvi...

Based on the clinical trial, there are certain expectations for how long patients can anticipate seeing the benefits of treatment. The median duration of response was 11.6 months (95% CI, 4.4 to...

This decision to remove REMS comes one year after the FDA loosened REMS requirements and removed the site mandate for CAR T educational and training materials because they deemed the product label...