18 October 2023
18 October 2023
The approval of ZILBRYSQ is based on the placebo-controlled, double-blind, randomised, multi-centre Phase III RAISE study.
The latest Keytruda/chemotherapy approval marks the sixth setting in NSCLC where the PD-1 inhibitor is FDA-approved.
The positive opinion expands the antiviral drug’s use to CMV-positive donors and CMV-negative kidney transplant patients at high risk of CMV infection.
The Netherlands-based company’s treatment has been awarded the designation by the US FDA following a successful Phase I trial.
LSTA1 is expected to alter the tumour microenvironment, making tumours more susceptible to immunotherapies.
The extended agreement will focus on developing checkpoint inhibitors in cancer, with two anti-PD1 antibodies in preclinical development.
SpliceBio will license Spark Therapeutics’ propriety protein splicing platform to develop a gene therapy for renal disease.
The US BARDA contract will sponsor the development of the company’s plasma gelsolin for treating acute respiratory distress syndrome.
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With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.
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