Drug Approval | July 24, 2025
NATCO Pharma API unit in Mekaguda receives EIR from USFDA
The company received one observation in the Form-483
The company received one observation in the Form-483
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
The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks
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)
Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date
Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use
Aims to support healthcare practitioners with evidence-based cough categorization tools that enable choosing the right molecules for effective & targeted relief from cough
Plant-based chemistries have an outsized role to play for the HPC sector by meeting demand for good, gentle, and green products
Enables additional US manufacturing capacity to serve increased demand for pharma/biotech customers
New platform powered by Opentrons expands lab automation to accelerate scientific discovery
Subscribe To Our Newsletter & Stay Updated
