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Orphan Status for Biliary Tract Cancer Drug

[ Price : $8.95]

FDA grants Nuvectis Pharmas NXP800 an orphan drug designation for treating biliary tract cancer.

Pentax Endoscope and Video Processor Cleared

[ Price : $8.95]

FDA clears a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope.

Priority Review for Serviers Tibsovo sNDA

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FDA says it will give priority review to a Servier sNDA seeking a new indication for Tibsovo to treat some adult myelodysplastic s...

Abortion Drug Can Remain on Market: Appeals Court

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The Fifth Circuit Court of Appeals rules that the abortion drug mifepristone can remain on the market while litigation continues.

FDAs Lighter Enforcement May be Ending: Attorney

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Attorney Douglas Farquhar says an FDA trend toward more enforcement discretion for drug company inspections with official action i...

New FDA PathologAI Initiative

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The FDA National Center for Toxicological Research says initial results from its new PathologAI initiative in preclinical animal s...

Panel to Discuss Neuroblastoma NDA

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Federal Register notice: FDA announces a 10/4 Oncologic Drugs Advisory Committee meeting to review a World Meds NDA eflornithine t...

Final Guide on Informed Consent

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Federal Register notice: FDA makes available a final guidance entitled Informed Consent: Guidance for Institutional Review Boards,...

Comments Reopened on Medicated Articles Guide

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Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medica...