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18 FDA Info Collections Okd by OMB

[ Price : $8.95]

Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.

Companion Diagnostic for Retevmo Approved

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FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selp...

Alnylam Gets Complete Response on sNDA

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FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyo...

Biocon Gets Insulin Aspart BLA Rejection

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FDA issues Biocon Biologics a complete response letter on its BLA for insulin aspart.

Breakthrough Status for Knee Implant

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FDA grants ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to delay or elimin...

11 Dr. Reddys ANDAs Withdrawn

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Federal Register notice: FDA withdraws 11 ANDAs from Dr. Reddys Laboratories after the company requested the actions because the p...

HistoSonics De Novo for Tumor Blaster

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FDA grants HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy t...

AstraZeneca Seeks More Input on Study Diversity

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AstraZeneca urges FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors s...

Sun Pharma NDA for Alopecia Areata

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FDA accepts for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janu...

2 Covid-19 Product EUAs Revoked

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Federal Register notice: FDA announces the revocation of two Monkeypox-related Emergency Use Authorizations after the authorizatio...