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ImmunityBio Refiles Bladder Cancer BLA

[ Price : $8.95]

ImmunityBio refiles its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating patients with BCG-u...

Complete Response on Dupixent sBLA

[ Price : $8.95]

FDA sends Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chroni...

Medtronic Warning on McGrath Video Laryngoscopes

[ Price : $8.95]

FDA posts a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have bee...

Keytruda Positive Data in Cervical Cancer

[ Price : $8.95]

Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% ...

Guide on Drug Benefit-Risk Assessments

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Benefit-Risk Assessment for Human Drug and Biological Produ...

Enhanced Coronary Lithotripsy Catheter OKd

[ Price : $8.95]

FDA approves a Shockwave Medical PMA for what the company calls an enhanced Shockwave C2+ Coronary Intravascular Lithotripsy cathe...

Regenerative Therapy Consensus Standards Guide

[ Price : $8.95]

Federal Register notice: FDA releases a final guidance entitled Voluntary Consensus Standards Recognition Program for Regenerative...

Pfizer Pentavalent Meningococcal Vaccine Approved

[ Price : $8.95]

FDA approves Pfizers Penbraya (meningococcal groups A, B, C, W and Y vaccine), a pentavalent vaccine that protects against the mos...

Philips Respironics Recalls V60 Ventilators

[ Price : $8.95]

Philips Respironics recalls its V60 Ventilators and V60 Plus Ventilators because the devices contain power management printed circ...

Arrest Made in Misbranded Device Case

[ Price : $8.95]

The U.S. government arrests a Chinese citizen related to a criminal complaint about manufacturing and distributing misbranded medi...