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Biologics

FDA accepts for filing Ilex Oncology's 12/23/99 BLA for Campath (alemtuzumab), an investigational hu...

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Biologics

FDA posts its agenda for an upcoming public meeting on spine and other orthopedic use of human bone ...

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Biologics

FDA's Center for Biologics Evaluation and Research yesterday posted the review and approval document...

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Biologics

CBER says Alpha Therapeutic Corp. has requested that all stock of two lots of its immune globulin in...

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Biologics

CBER has cleared Baxter Healthcare's 510(k) application for its Sepacell pre-storage leukocyte reduc...

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Biologics

FDA has granted priority review status to Wyeth Lederle Vaccines' investigational pneumococcal conju...

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Biologics

Coulter Pharmaceutical and SmithKline Beecham say FDA has granted priority review for Bexxar (tositu...

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Biologics

Stryker Corp. says FDA has accepted for filing its PMA for the OP-1 Implant to treat long bone union...

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Biologics

FDA sends Aeglea BioTherapeutics a refusal-to-file letter for its BLA for pegzilarginase, indicated ...

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Biologics

Some 18 members of Congress ask FDA 19 questions about Covid-19 vaccine safety in children under age...

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Biologics

FDA delays making a decision on Novavaxs Covid-19 vaccine emergency use authorization request after ...

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Biologics

As FDA prepares for a 6/14-15 advisory committee meeting on pediatric Covid-19 vaccines, agency brie...

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Biologics

CBER updates its guidance agenda for 2022 containing 18 guidances it plans to develop.

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Biologics

An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emerg...

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Biologics

Krystal Biotech files a BLA for B-Vec (beremagene geperpavec), a topical gene therapy for treating p...

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Biologics

FDA publishes a draft guidance on the voluntary consensus standards recognition program for regenera...

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Biologics

FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes to recommend the ...

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Biologics

Six stakeholders provide comments to FDA on the agencys docket on human gene therapy products incorp...

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Biologics

FDA authorizes Modernas Covid-19 vaccine and Pfizer-BioNTechs Covid-19 vaccine for use in children a...

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Biologics

FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 v...