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2 Guides on Drug Interaction Studies

[ Price : $8.95]

Federal Register notice: FDA releases two final guidances on drug interaction studies.

Priority Review Voucher for Vyondys 53 Approval

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Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application Sa...

Draft Guide for Levonorgestrel ANDAs

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Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Levonorgestrel.

Guide on Biomarker for Hematologic Malignancy Drugs

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FDA posts a final guidance on Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Developme...

Oncologic Panel to Review 2 Product Submissions

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Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting that will discuss a Steba Biotech NDA for...

FDA Seeks Computational Algorithms for Adverse Events

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FDA seeks outside groups or individual data scientists to develop computational algorithms to identify adverse event anomalies in ...

Epizymes Tazverik Gets Accelerated Approval

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FDA grants accelerated approval for Epizymes Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older wit...

Abbott Expanded Indication for Brain Stimulator

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FDA approves an expanded indication for Abbotts Infinity Deep Brain Stimulation system to include targeting of an area of the brai...

Tecentriq Study in Urothelial Cancer Misses Endpoint

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A Genentech Phase 3 study of Tecentriq (atezolizumab) in people with muscle-invasive bladder (urothelial) cancer misses its primar...

King Vision Video Laryngoscopes Recalled

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King Systems recalls 171 units of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image.