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FDA Broadens Dextenza to Include Ocular Itching

[ Price : $8.95]

FDA approves an Ocular Therapeutix supplemental NDA to broaden Dextenzas (dexamethasone ophthalmic insert) label to add an additio...

Enzyvant Therapeutics Athymia Tissue-based Product OKd

[ Price : $8.95]

FDA approves Enzyvant Therapeutics thymus tissue-based product Rethymic for treating pediatric patients with congenital athymia, a...

Athenex Scraps NDA on Paclitaxel Plus Encequidar

[ Price : $8.95]

Athenex decides to abandon its continued development of oral paclitaxel plus encequidar for treating metastatic breast cancer afte...

FDA Grants Y-mAbs Pediatric Disease Designation

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FDA grants Y-mAbs Therapeutics a rare pediatric disease designation for the companys lutetium-labeled omburtamab antibody program ...

ChemoCentryx Vasculitis Drug Approved

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FDA approves a ChemoCentryx NDA for Tavneos (avacopan) as an add-on treatment for adult patients with severe active anti-neutroph...

Panel Unanimously Backs Takeda Cytomegalovirus Drug

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FDAs Antimicrobial Drugs Advisory Committee votes 17-0 to recommend approval of Takedas maribavir to treat cytomegalovirus infecti...

Labeling Recommendations for Surgical Staplers

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Federal Register notice: FDA announces a final guidance entitled Surgical Staplers and Staples for Internal Use Labeling Recommen...

Surgical Staplers Up-classified to Class 2

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Federal Register notice: FDA issues a final order to reclassify surgical staplers for internal use from Class 1 into Class 2 and s...

FDA Outlines Novel Excipient Pilot Program

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FDA outlines a new pilot program on using novel excipients with the intent to increase their use in drug development, especially i...

Janssen Stelara Juvenile Psoriatic Arthritis sBLA

[ Price : $8.95]

Janssen Pharmaceutical files a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and olde...