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Alert Issued on Vantives Prismaflex Systems

[ Price : $8.95]

FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after...

Clinical Hold Lifted on GH Research Antidepressant

[ Price : $8.95]

FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in th...

Novartis Wins Breakthrough Status for Ianalumab

[ Price : $8.95]

FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.

Teclistamab Cuts Myeloma Risk of Progression by 71%: J&J

[ Price : $8.95]

Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli ...

Scholar Rock Plans BLA Resubmission for Apitegromab

[ Price : $8.95]

Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscul...

IND Review Procedures SOPP

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CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.

Compounder Says Lilly, Novo Nordisk Violate Antitrust

[ Price : $8.95]

Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are viol...

Inspection Flags Sanitation, Quality Control Lapses at Biocon

[ Price : $8.95]

FDA cites Biocon Biologics for a series of manufacturing and quality control deficiencies following an inspection of the companys ...

BD New Breast Biopsy System Cleared

[ Price : $8.95]

FDA clears a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinician...

8 Observations in Shilpa Medicare 483

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FDA releases the form FDA-483 with eight observations from an inspection at Indias Shilpa Medicare drug manufacturing facility.