Food and Drug Administration (FDA)
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The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
January isn’t a particularly busy month for PDUFA dates for the U.S. Food and Drug Administration, with only two scheduled for the month. Here’s a look.
Posimir is a non-opioid being developed for post-surgical pain. It is designed to be injected into the surgical site, where it delivers bupivacaine for up to three days post-surgery.
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
In a painful blow to the San Francisco-based company, the committees voted unanimously, 27 to 0, not to recommend approval.
With the 2020 elections looming though, and lawmakers across the country drafting legislation aimed at curbing price increases, some companies are carefully examining the landscape as they approach pricing.
With a new year underway, the U.S. Food and Drug Administration is doing some house-cleaning of sorts.
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