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Complete Response on Lumbar Disc Herniation BLA

[ Price : $8.95]

FDA sends Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar...

FDA Delays Decision on Breast Cryoblation Device

[ Price : $8.95]

FDA delays its decision on an IceCure Medical de novo marketing authorization request for the ProSense cryoblation device and its ...

Pancreatic Cancer Drug Gets Orphan Status

[ Price : $8.95]

FDA awards PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer.

BD Alaris Pump Software Being Corrected

[ Price : $8.95]

Becton, Dickinson corrects software for the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter after recei...

FDA Revokes EUAs on 3 Beckman Coulter Tests

[ Price : $8.95]

Federal Register notice: FDA revokes Emergency Use Authorizations issued to Beckman Coulter for three of its Access branded Covid-...

Aspen Pharmacare CGMP Violations

[ Price : $8.95]

FDA warns South Africas Aspen Pharmacare about CGMP violations in its production of finished drugs as a contract manufacturing fac...

FDA Accepts Alvotech AVT03 BLA

[ Price : $8.95]

FDA accepts a BLA submitted by Dr. Reddys and Alvotech for a biosimilar form of Amgens Prolia and Xgeva.

CGMP Violations at Canadas Vegewax Candleworx

[ Price : $8.95]

FDA warns Concord, Ontario, Canada-based Vegewax Candleworx about CGMP violations in its production of finished drugs.

Smiths Medical Recalls Venous Access System

[ Price : $8.95]

Smiths Medical recalls its ProPort Plastic Venous Access System because the devices plastic port housing and port reservoir may se...

2 ICH Guidelines Advance

[ Price : $8.95]

The International Council for Harmonization says the M11 and M13B guidelines have advanced to the second public consultation.