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Penumbra Recalls JET 7 Reperfusion Catheter

[ Price : $8.95]

Penumbra recalls all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology due to a risk of unexpect...

FDA Warns Against Some Online Male Products

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FDA cautions consumers not to use some male enhancement and weight loss products sold through Amazon and eBay.

Guidance on Drug Complex Innovative Trial Designs

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Federal Register notice: FDA posts a final guidance on interacting with the agency about drug complex innovative trial designs.

FDA Approves MacroGenics Margenza

[ Price : $8.95]

FDA approves MicroGenics Margenza for some HER2-positive metastatic breast cancers.

Takeda NDA for Eosinophilic Esophagitis Drug Accepted

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FDA accepts for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic eso...

Professors Say Too Few Reviewers on Pfizer Covid Vaccine

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Two university professors question FDAs decision to assign only one reviewer to several core scientific areas in the Pfizer Covid-...

Vaccine Panel Recommends EUA for Moderna Covid Vaccine

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An FDA advisory committee votes to recommend an Emergency Use Authorization for Modernas investigational Covid-19 vaccine (mRNA-12...

Info Collection on State Enforcement Notifications

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Federal Register notice: FDA seeks comments on an information collection extension entitled State Enforcement Notifications 21 CF...

Rhythm Pharma Granted Priority Review Voucher

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Federal Register notice: FDA announces the issuance of a priority review voucher to Rhythm Pharmaceuticals related to its rare ped...

Generic Drug Controlled Correspondence Guidance

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FDA publishes a guidance on how generic drug manufacturers can submit controlled correspondence to FDA seeking generic drug develo...