FDA warns Henderson, NV-based Steiner Biotechnology about multiple violations in its production and labeling of several dental bone grafting products.
FDA accepts for review a GSK supplemental BLA for Jemperli (dostarlimab) in combination with chemotherapy for treating certain adult patients with adv...
FDA warns Cypress, CA-based iRhythm Technologies about multiple violations in its production of the ZIO AT cardiac event reporting and reporting devic...
FDA grants a de novo marketing authorization for Cue Healths Cue Covid-19 Molecular Test, the first at-home Covid test granted a traditional marketing...
Norwich Pharmaceuticals asks the DC federal court to order FDA to grant final approval to the companys amended ANDA for generic rifaximin to treat irr...
PhRMA says it generally agrees with recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in drug man...
CDER and Oncology Center of Excellence researchers say a pooled analysis showed the frontline immune-oncology/tyrosine kinase inhibitor combination th...
FDA issues an import alert on drug products manufactured by Sun Pharmaceutical Industries in Gujrat, India due to significant GMP violations documente...
