Jemperli RUBY phase III trial met its primary endpoint
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
Steve joins Sai Life Sciences from GlaxoSmithKline (GSK) where he was a department head and member of the global chemical development leadership team.
She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy
Revenue is up 23% whereas Profit After Tax expands 29% for the company
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
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