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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.

QS, MDR, UDI Issues in Levo AG Inspection

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

Repeat CGMP Violations at Guangxi Yulin

[ Price : $8.95]

A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found r...

FDA Orphan Status for Netherton Syndrome Drug

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FDA grants Quoin Pharmaceuticals an orphan drug designation for QRX003 and its use in treating Netherton syndrome.

Genentechs Gazyva Approved for Lupus Nephritis

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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...