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Leaked Documents Questioned Pfizer Vaccine Manufacturing: BMJ

[ Price : $8.95]

The BMJ reports that leaked documents from a cyberattack at the European Medicines Agency late last year revealed that regulators ...

TherapeuticsMD Wants Limits on Generic Annovera

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TherapeuticsMD asks FDA to impose restrictions on any marketing application for a generic form of its Annovera birth control produ...

CDRH Sets Streamlined Path for Covid Test EUA

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FDA provides information for Covid-19 test developers and organizations establishing a Covid testing program.

Study on Drug Names and Efficacy Perceptions

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Federal Register notice: FDA sends to OMB an information collection entitled Empirical Study of Promotional Implications of Propri...

Panel To Review 3 Accelerated Approved Drugs

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Federal Register notice: FDA announces a 4/27-29 Oncologic Drugs Advisory Committee meeting to hear updates on certain supplementa...

Info Collection on Biologic Samples/Protocols

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Federal Register notice: FDA seeks comments on an information collection extension entitled Request for Samples and Protocols.

Trial Stopped Early on Libtayo in Cervical Cancer

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Sanofi and Regeneron stop a Phase 3 clinical trial on PD-1 inhibitor Libtayo (cemiplimab) based on positive data and now plan an F...

Safety Alert on Stryker Ankle Replacement

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FDA issues a safety alert on Strykers Scandinavian Total Ankle Replacement device due to a higher than expected risk of the device...

PharmaEssentia Gets FDA Complete Response

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FDA issues PharmaEssentia a complete response letter on its BLA for ropeginterferon alfa-2b-njft for treating polycythemia vera, r...

Clinical Hold Lifted on Histogen Cartilage Stimulator

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FDA lifts a clinical hold against a Histogen IND application package for a planned Phase 1/2 clinical trial of its HST-003, which ...