Drug Approval | February 18, 2022
USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences
The partnership will help digitize and automate existing tasks traditionally managed on paper, significantly reducing costs and lead times while increasing compliance
Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Canada
The newly enhanced drug development platform will help empower innovators with the fastest development timelines
Dr. Raman has succeeded Victoria Richon
Evonik invests in start-up to improve patient recovery after open-chest surgery
Agilent will integrate the technology into its lab informatics platforms, enabling customers to automate GC/MS data analysis
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
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