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bluebird bio Wins Priority Voucher

[ Price : $8.95]

Federal Register notice: FDA issues bluebird bio a priority review voucher for obtaining approval of Zynteglo (betibeglogene autot...

BMS, Janssen Moving Stroke Drug to Phase 3

[ Price : $8.95]

After reporting Phase 2 data, Bristol Myers Squibb and Janssen Pharmaceuticals say they are planning to begin a Phase 3 trial of t...

Alert on Respironics Airway Pressure Devices

[ Price : $8.95]

FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a...

Guide on Evaluation of QT/QTc Interval Prolongation

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance for industry entitled E14 and S7B Clinical and Nonclinical Evaluatio...

Draft Guide on Pediatric Extrapolation

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled E11A Pediatric Extrapolation.

Drug Interaction Studies Draft Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled M12 Drug Interaction Studies.

Info Collection on User Fee Review Transparency

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Federal Register notice: FDA sends to OMB an information collection revision entitled Review Transparency and Communication for Ne...

FDA Issues EUA for Covid Test, Revokes 4 Others

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Federal Register notice: FDA announces the issuance of one, and revocation of four Emergency Use Authorizations issued to STS Lab ...

Moderna Files Patent Suit Against Pfizer/BioNTech

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Moderna files a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 v...

2 ICH Guidances on Drug Analytical Procedures

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FDA makes available two International Council for Harmonization draft guidances on drug analytical procedures.