Johnson & Johnson submits additional data to FDA on psoriatic arthritis
The submission is supported by results from the Phase 3b APEX study
The submission is supported by results from the Phase 3b APEX study
The latest BioE3 policy builds the framework for high-performance biomanufacturing to propel the development and production
This case report is jointly authored by US clinicians from leading hospitals, Houston Methodist Hospital, Weill Cornell Medical College and Johns Hopkins
Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision
The inspection was conducted from July 22-25, 2025
The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs
The company received one observation in the Form-483
The INSPIRE-1 and INSPIRE-2 trials are Phase 3 studies assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis (PsA)
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
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