FDA
Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).
Biom’up has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its HEMOBLAST Bellows Laparoscopic Applicator for all minimally-invasive procedures. Biom’up submitted the premarket approval (PMA) supplement to the FDA in July, 2018.
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
The partial government shutdown is 31 days old, yet the U.S. Food and Drug Administration has maintained a steady list of drug approvals throughout that time. However, that approval rate could change next month.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee had a split vote, 8 to 8, on whether the overall benefits of Zynquista (sotagliflozin) outweiged the risk in order to support approval. This sends things back to the agency to make a final decision, which has a target action date of March 22, 2019.
Immunomedics was hoping for a green light from the U.S. Food and Drug Administration for its triple-negative breast cancer treatment, sacituzumab govitecan. However, this morning the company announced that approval will not likely be coming any time soon.
This follows a 2017 rejection by the agency, requesting more data. As Jefferies analyst Michael Yee wrote in a note to clients, Amgen is “back in the game.”
Noting that the U.S. Food and Drug Administration (FDA) expects more than 200 investigational new drug applications (INDs) by 2020 per year, many of them cell and gene therapies, the agency issued an outline of new procedures it plans to implement this year.
In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
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