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House GOPers Seek IG Probe on FDA Lab Safety

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House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDAs oversight a...

Regulatory Review Period for Pfizers Vyndamax

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pfizers Vyndamax (tafamidis...

FDA OKs Vyloy for Rare Gastric Cancer

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FDA approves an Astellas Pharma BLA for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing ch...

Guide on Post-Op Nausea Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Pre...

Guide on Oncology Patient-Reported Outcomes

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Federal Register notice: FDA makes available a final guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials.

Guide on Neonatal Neurodevelopmental Safety Studies

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Federal Register notice: FDA makes available a final guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Sa...

Guide on ANDA Drug Master File Reviews

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FDA releases a guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. `

Gilead Pulls Trodelvy Urothelial Cancer Indications

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Gilead Sciences withdraws the accelerated approval for a Trodelvy (sacituzumab govitecan-hziy) indication for treating adult patie...

Avadel Wins Expanded Label for Lumryz

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FDA approves an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sl...

Boston Scientific Recalls Obsidio Embolic Device

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Boston Scientific recalls (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about r...