[ Price : $8.95]
CDERs Office of Surveillance and Epidemiology (OSE) discusses new and enhanced activities in postmarketing safety reviews.[ Price : $8.95]
Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduce the Protecting and Transforming Cyber Health Care Act that would i...[ Price : $8.95]
FDA posts a one-item Form FDA-483 for Catalent Biologics (Bloomington, IN) from a 2020 inspection at the manufacturing site.[ Price : $8.95]
FDA grants ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patien...[ Price : $8.95]
FDA extends by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in i...[ Price : $8.95]
Y-mAbs Therapeutics resubmits a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma that ad...[ Price : $8.95]
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product that also include a unique Quick Response code t...[ Price : $8.95]
Epstein Becker & Green attorney James Boiani believes Congress will step in to clarify that contrast agents should be regulated as...