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Lancet Oncology Commission Priorities

[ Price : $8.95]

The Lancet Oncology Commission outlines future cancer research priorities for the U.S. Cancer Moonshot.

Advisors Back Indivior Opioid Use Disorder Drug

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Members of two FDA advisory committees vote to recommend approval of Indiviors RBP-6000 for treating adults with opioid use disord...

FDA Clears Luminex Aries Strep Assay

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FDA clears a Luminex 510(k) for the ARIES Group A Strep Assay for detecting Streptococcus pyogenes from throat swab specimens usin...

Comments on Device Software Change Guidance

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Stakeholders raise varying issues on an FDA draft guidance on submitting a 510(k) for medical device software changes.

Novartis sBLA for Kymriah in Lymphoma Patients

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Novartis files a supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion for treating adult patients w...

FDA Gets Injunction Against Philips Defibrillators

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A Massachusetts federal judge signs a consent decree barring Philips North America from manufacturing automatic external defibrill...

Draft ICH Guidance on Drug Trial Statistical Principles

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Federal Register notice: FDA makes available an International Council for Harmonization draft guidance entitled E9 (R1) Statistica...

Workshop on Opioid Packaging/Storgage/Disposal

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Federal Register notice: FDA announces a 12/11-12 public workshop on Packaging, Storage, and Disposal Options To Enhance Opioid Sa...

FDA Denies PEG 3350 Selenium Petition

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FDA denies an Empire State Consumer Project petition asking that it test PEG 3350 products for selenium and recall any such produc...

FDA Denies PMRS Requested Stay of Roxybond Approval

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FDA denies a Pharmaceutical Manufacturing Research Services petition seeking a stay in the effective date of agency approval of In...