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Biologics
FDA accepts for filing Ilex Oncology's 12/23/99 BLA for Campath (alemtuzumab), an investigational hu...
Biologics
FDA posts its agenda for an upcoming public meeting on spine and other orthopedic use of human bone ...
Biologics
FDA's Center for Biologics Evaluation and Research yesterday posted the review and approval document...
Biologics
CBER says Alpha Therapeutic Corp. has requested that all stock of two lots of its immune globulin in...
Biologics
CBER has cleared Baxter Healthcare's 510(k) application for its Sepacell pre-storage leukocyte reduc...
Biologics
FDA has granted priority review status to Wyeth Lederle Vaccines' investigational pneumococcal conju...
Biologics
Coulter Pharmaceutical and SmithKline Beecham say FDA has granted priority review for Bexxar (tositu...
Biologics
Stryker Corp. says FDA has accepted for filing its PMA for the OP-1 Implant to treat long bone union...
Biologics
FDA sends Aeglea BioTherapeutics a refusal-to-file letter for its BLA for pegzilarginase, indicated ...
Biologics
Some 18 members of Congress ask FDA 19 questions about Covid-19 vaccine safety in children under age...
Biologics
FDA delays making a decision on Novavaxs Covid-19 vaccine emergency use authorization request after ...
Biologics
As FDA prepares for a 6/14-15 advisory committee meeting on pediatric Covid-19 vaccines, agency brie...
Biologics
CBER updates its guidance agenda for 2022 containing 18 guidances it plans to develop.
Biologics
An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emerg...
Biologics
Krystal Biotech files a BLA for B-Vec (beremagene geperpavec), a topical gene therapy for treating p...
Biologics
FDA publishes a draft guidance on the voluntary consensus standards recognition program for regenera...
Biologics
FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes to recommend the ...
Biologics
Six stakeholders provide comments to FDA on the agencys docket on human gene therapy products incorp...
Biologics
FDA authorizes Modernas Covid-19 vaccine and Pfizer-BioNTechs Covid-19 vaccine for use in children a...
Biologics
FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 v...
