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Unived Marketing Unapproved Drugs: FDA

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FDA warns Unived it is marketing misbranded unapproved new drugs.

Immune & Genetics Protocols Marketing Unapproved Drug: FDA

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FDA warns Immune & Genetics Protocols that it is marketing a misbranded unapproved new drug.

Workshop on Orthopedic Device Postmarket Duties

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FDA announces a 6/10 virtual public workshop on orthopedic device postmarket programs and activities.

FDA Touts Complex Generic Drug Efforts

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Office of Generic Drugs Research and Standards director Robert Lionberger says FDA is taking many steps to promote the development...

2 Clinical Outcome Assessment Pilot Grants Made

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FDA identifies recipients of two grants under the CDER Standard Core Clinical Outcome Assessments and their Related Endpoints pilo...

Pfizer Seeking Covid-19 Vaccine Full Approval

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Pfizer says it will ask FDA by the end of the month to convert its Covid-19 vaccines emergency use authorization to a full BLA app...

Policy Statement on Drug Review Withdrawn

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HHS and FDA withdraw a 1/15 Statement of Policy directing the agency to publish certain information regarding the timeline for its...

AstraZenecas Farxiga OKd for Kidney Disease

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FDA approves AstraZenecas Farxiga (dapagliflozin) to reduce the risk of glomerular filtration rate decline, end-stage kidney disea...

Intra-Cellular Therapies sNDA for Bipolar Depression

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FDA accepts for review an Intra-Cellular Therapies supplemental NDA for lumateperone, indicated for treating depressive episodes a...

HutchMed NDA for Pancreatic Tumor Therapy

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HutchMed completes a rolling NDA submission for surufatinib for treating pancreatic and extra-pancreatic neuroendocrine tumors.