On February 2, 2025, Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA.
The FDA has accepted a BLA for review, seeking approval of HLX11, an investigational biosimilar of pertuzumab, for use in certain patients with HER2-positive breast cancer. 1 Pertuzumab is ...
Trastuzumab deruxtecan is approved for HR-positive, HER2-low/ultralow metastatic breast cancer post-endocrine therapy, based on DESTINY-Breast06 trial results. The trial showed a 36% reduction in ...
“The RBI’s decision to allow applicability of nearly all FDI provisions for downstream investments is a significant liberalization measure. Share swap transactions and deferred payment terms are now ...
The steps are organized so you'll build upon what you previously learned with each new piece of information. Due diligence is an investigation of a potential investment such as a stock to confirm ...
We have an approval…[for] a medication called trastuzumab deruxtecan [Enhertu; AstraZeneca], which is an ADC [antibody-drug conjugate] in second line or beyond. 2 It’s a great medication with ...
Shell's director of downstream, renewables and energy solutions ... be replaced by Machteld de Haan from April 1. Vigeveno will step down from the role on March 31. Haan has been executive ...