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Genentechs Gazyva Approved for Lupus Nephritis

[ Price : $8.95]

FDA approves Genentechs Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard t...

Major Staff Losses at CDER and CBER Amid Shake-up

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FDA releases hiring data showing steep declines in staffing at CDER and CBER.

CGMP Violations Seen in BRS Services Inspection

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FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.

GSK and Speros Antibiotic Positive Phase 3 Results

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GSK and Spero Therapeutics report positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated u...

FDA Strengthens Tranexamic Acid Warning

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FDA says it is strengthening labeling for tranexamic acid injection products to clarify that it is only to be administered intrave...

FDA Contracts with ISMP on Medication Errors

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FDA contracts with the Institute for Safe Medication Practices for services to strengthen its ability to identify and reduce the r...

Workshop on Patch Tests for Allergic Contact Dermatitis

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FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic...

Replimune BLA Resubmission for Melanoma Therapy

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FDA accepts for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating...

Roches Giredestrant Combo Shows Positive Phase 3 Data

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Roche reports new favorable data from the Phase 3 evERA Breast Cancer study of its investigational oral therapy giredestrant, used...

Cell, Gene Therapy Monitoring Guide Encouraging: Attorneys

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Attorneys at Hyman, Phelps & McNamara say they are encouraged by an FDA draft guidance outlining a roadmap for postapproval monito...