Drug Approval | June 19, 2023
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with the facility receiving an inspection classification of NAI
Urges Innovators to produce quality products that can be deployed at scale
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
Convergent action on AMR identified as an important area of intervention
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The company will submit its comprehensive response on these observations to the US FDA
Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS portfolio
Economic analysis of cost of Vall d’Hebron University Hospital Stroke Unit shows direct-to-angio stroke pathway can save more than USD 3,000 per patient
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