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CBER director Peter Marks says there is a positive risk/benefit assessment for CAR-T therapy for its approved uses.[ Price : $8.95]
CDER director Patrizia Cavazzoni says ORP director Elizabeth Jungman will become FDA commissioner Robert Califfs chief of staff.[ Price : $8.95]
FDA cautions that there is the potential for elevated levels of formaldehyde being released when two GE HealthCare compressors are...[ Price : $8.95]
FDA warns Czechias Deymed Diagnostic about QS violations in its production of non-sterile Class 2 medical devices.[ Price : $8.95]
FDA warns Ponce, Puerto Rico-based Prime Labs about significant CGMP regulation violations in its production of finished drugs.[ Price : $8.95]
Leiters Health recalls 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpo...[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher (pediatric disease product) to Vertex Pharmaceuticals for gaining ap...[ Price : $8.95]
FDA approves Bausch + Lombs Teneo Excimer Laser Platform for LASIK vision correction surgery for myopia and myopic astigmatism.