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Petition Seeks Ban on Music in DTC Ads
[316 Words]
[ Price : $8.95]
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| A citizen petition asks FDA to ban music in direct-to-consumer television, radio and internet streamed advertisements because it distracts the audience’s attention from product side effects and contraindications. |
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08/03/2020
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Janssen sNDA for Spravato OK’d for Major Depression
[244 Words]
[ Price : $8.95]
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| FDA approves a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. |
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08/03/2020
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Submission Data Elements for Imported Vet Devices
[95 Words]
[ Price : $8.95]
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| Federal Register proposed rule: FDA proposes to amend its regulations to require that certain data elements be submitted for veterinary devices that are being imported. |
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07/31/2020
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FDA Withdraws Watson Generic Oxycodone/Ibuprofen
[81 Words]
[ Price : $8.95]
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| Federal Register notice: FDA withdraws approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets, indicated for relieving pain. |
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07/31/2020
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Genentech Triple Combo OK’d for Melanoma
[183 Words]
[ Price : $8.95]
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| FDA approves a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for treating BRAF V600 mutation-positive advanced melanoma patients. |
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07/31/2020
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FDA Adds 4 APIs to Compounding List
[153 Words]
[ Price : $8.95]
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| Federal Register notice: FDA identifies four drug substances to be added to its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for use in drug compounding. |
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07/31/2020
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BMS/Bluebird Resubmit BLA for Multiple Myeloma
[212 Words]
[ Price : $8.95]
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| Bristol Myers Squibb and Bluebird Bio re-file their BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma. |
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07/31/2020
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Catalyst Loses NDA Lawsuit Against FDA
[206 Words]
[ Price : $8.95]
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| Catalyst Pharmaceuticals loses against FDA in a lawsuit over the agency's approval of competitor Jacobus Pharmaceutical’s Ruzurgi (amifampridine). |
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07/31/2020
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