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Takeda NDA for Eosinophilic Esophagitis Drug Accepted

[ Price : $8.95]

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...

Priority Review Voucher Awarded to Eiger BioPharm

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Federal Register notice: FDA issues of a priority review voucher to Eiger BioPharmaceuticals that is related to its rare pediatric...

FDA Advisors Back Greater Entresto Use

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FDA advisors back an expanded indication for Novartis heart failure drug Entresto but cant specify a patient group.

ACL Implant Gains De Novo Authorization

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FDA grants a de novo marketing authorization for Miach Orthopedics anterior cruciate ligament (ACL) implant for ACL reconstruction...

Abbott Virtual At-Home Covid Test Gets EUA

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FDA issues Abbott an Emergency Use Authorization for its virtually guided at-home use BinaxNOW Covid-19 Ag Card rapid test for det...