Food and Drug Administration (FDA)
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The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.
The advisory committee voted 19-0 to recommend the extra dose of the J&J shot for anyone 18 years and older.
The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
The FDA gave Ardelyx a CRL on the NDA but did not mention anything about clinical pharmacology or biopharmaceutics, safety, or any related non-clinical concerns.
Today’s approval was based on the Phase III KEYNOTE-826 trial that evaluated Keytruda and chemotherapy with or without bevacizumab compared to the same chemotherapy treatment.
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