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3rd Patient-Focused Drug Development Guidance

[ Price : $8.95]

FDA publishes the third in a series of guidances on aspects of collecting patient experience data to be used in medical product de...

sBLA for PadcevKeytruda Combo in Bladder Cancer

[ Price : $8.95]

FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...

Fast Track for Myosin Glioblastoma Drug

[ Price : $8.95]

FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.

Major Staff Losses at CDER and CBER Amid Shake-up

[ Price : $8.95]

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

CGMP Violations Seen in BRS Services Inspection

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

QS, MDR, UDI Issues in Levo AG Inspection

[ Price : $8.95]

FDA warns Switzerlands Levo AG about Quality System, Medical Device Reporting, and Unique Device Identifier violations in its prod...