Infections with H. pylori affect over 43 percent of the world’s population with a wide range of gastrointestinal disorders
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Data builds on promising signal published last week, underscoring the importance of sotrovimab for early treatment of COVID-19
Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron
The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
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