Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
The facility was inspected from May 7 to May 17, 2024
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
Subscribe To Our Newsletter & Stay Updated
