FDA CRL Delays ViiV’s Long-Acting Cabotegravir Regimen
Manufacturing Questions Triggered FDA Complete Response Letter
ViiV Healthcare will not be able to launch its cabotegravir and rilpivirine long-acting HIV treatment in January after receiving an FDA Complete Response Letter.
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Keeping Track: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
If bad luck comes in threes, GSK will be delighted to see the end of this week with dostarlimab approval delayed, bintrafusp failing in lung cancer and a Phase II of an ulcerative colitis drug discontinued.
Roche’s Phesgo may lower healthcare costs in Europe for treating breast cancer following its approval by European Commission. Other just-approved products nearing the EU market are ViiV’s Vocabria, to be used with Janssen’s Rekambys/Edurant, as a long-acting injectable HIV therapy, and Aimmune’s peanut allergy therapy, Palforzia.