PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection
A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
Expansion of leading biomarker and bioanalysis company enhances bioanalytical solutions for targeted radiopharmaceuticals
It is part of the company's CAD $30 million capital investment in the Aurora, Canada site
As part of large-scale clinical studies prior to market introduction, the AI software has now gone into clinical test with patients, so-called first-in-human applications
City of Hope is first in world to test oncolytic virus, CF33-hNIS, in people with metastatic solid tumours
Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series
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