The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan
Laurus will be incentivised for a portion of its development and commercialisation costs. CHAI will also provide technical and regulatory support to enable accelerated generic development
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.
This therapy may provide the first potential oral treatment for COVID-19, recognizing the global emergency of new SARS-CoV-2 variants
Preclinical and early human data indicate BriLife may confer enhanced immunity against Delta variant
Arch Pharma Labs has filed the application
Ranitidine Hydrochloride is an important product for Solara and is manufactured at its Cuddalore site
Subscribe To Our Newsletter & Stay Updated
