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Priority Review Voucher Awarded to Eiger BioPharm

[ Price : $8.95]

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...

Develop Clinical Trial Data Strategy: Consultants

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YourEncore consultants describe in a white paper the value of having a clinical trial data strategy.

Grassley, Wyden Track Company Payments to Pain Groups

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Sens. Grassley and Wyden call for greater transparency in regulated industry payments to tax-exempt advocacy groups.

15 Observations in Advanced Nutriceuticals FDA-483

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FDA releases the FDA-483 detailing 15 inspection observations from an inspection at Advanced Nutriceuticals, a sterile drug produc...

EMD Serono Comments on Cybersecurity Communications

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EMD Serono suggests ways to improve an FDA discussion paper on communicating cybersecurity vulnerabilities to patients.

Feds Discuss Pfizer Vaccine Manufacturing Issues

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Federal officials report to the media that Pfizer is experiencing some vaccine manufacturing issues.

Gilead Abandons Jyseleca for RA in the U.S.

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Gilead Sciences and Galapagos abandon the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis after a recent meetin...