Food and Drug Administration (FDA)
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A recent study questions if the FDA and other regulatory agencies worldwide rush certain approvals, particularly at the end of the year in a kind of “desk-clearing” activity.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.
The company said Fiasp is the “first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.”
Three months after it won approval in type 2 diabetes, AstraZeneca’s Farxiga is eying potential regulatory win as a treatment in heart failure patients.
Company will present at Biotech Showcase™ 2020 on Monday, 01/13/20 at 11:15am PST in San Francisco, CA
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.
The clinical trials the approval is based on suggested the drug was effective for treating primary insomnia but may also be effective for insomnia associated with other diseases, such as depression.
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
The FDA issued a Complete Response Letter for its combination treatment of cabotegravir and rilpivirine.
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