Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
Decision on EU marketing authorisation for this population expected by September 2024
Integrated Disease Surveillance Programme (IDSP) strengthened to improve disease surveillance and rapid data reporting
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
Imfinzi also recommended for patients with mismatch repair deficient disease
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
First immunotherapy regimen before and after surgery to extend survival in bladder cancer
Subscribe To Our Newsletter & Stay Updated
