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FDA Approves BMS Orencia for Graft Versus Host Disease

[ Price : $8.95]

FDA approves a new indication for Bristol-Myers Squibbs Orencia to prevent acute graft versus host disease in combination with imm...

FDA Approves Xeljanz for Ankylosing Spondylitis

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FDA approves a Pfizer supplemental NDA for its JAK inhibitor Xeljanz /Xeljanz XR (tofacitinib) for treating adults with active ank...

Oncologic Panel to Review Lung Cancer Therapy

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Federal Register notice: FDA announces a 2/10/2022 Oncologic Drugs Advisory Committee meeting that will vote on an Innovent Biolog...

FDA Withdraws 6 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the prod...

Info Collection on Expanded Access

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Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drug...

Pfizer Covid Oral Drug 89% Effective

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Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug signi...

Significant HCT/P Deviations at Cooper Institute

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FDA warns Houstons Cooper Institute for Advanced Reproductive Medicine about significant deviations from the regulations for human...

Covid-19 Actemra REMS Guidance

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FDA issues a guidance modifying REMS requirements for Genentechs Actemra under certain conditions during the Covid-19-related Acte...

FDA Approves 2 Svelte Stent Systems

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FDA approves two Svelte Medical drug-eluting stent systems.

Multiple Violations Found in Sanitor Inspection

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FDA warns Stanton, CA-based Sanitor about CGMP and other violations in its manufacturing of misbranded unapproved new drugs.