FDA grants Pfizer’s Lorlatinib breakthrough designation for NSCLC
Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine

Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine

Ezetimibe and simvastatin tablets are a prescription medicine that contains two cholesterol lowering medicines, ezetimibe and simvastatin, which are used along with diet to: Lower the level of

Several additional new investors participated in the financing, including GV (formerly Google Ventures) and Alexandria Venture Investments. The company’s existing investors, including OrbiMed, Polaris Venture Partners, SV Health

This designation is based on results from the ongoing, dose-ranging Phase 1-2 study that show a near cessation of spontaneous bleeding in patients with severe disease at up

The round included new strategic investments from Amgen Ventures, as well as participation from all existing investors Lux Capital, Redmile Group, dRx Capital (a Qualcomm and Novartis joint

Clinical cure was the primary endpoint of the study and defined as a complete resolution of all signs and symptoms of infection. In addition, patients treated with Zavicefta

Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor. Elias Zerhouni, M.D., President, Global R&D, Sanofi said: “Rheumatoid arthritis is a painful and debilitating disease

NGM282, which is a non-tumorigenic, engineered variant of the human hormone FGF19, demonstrated a significant reduction in liver fat content and improvement of biomarkers associated with the resolution

Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz, said: "We are proud to help patients in Europe with blood cancers and immunological diseases by improving their

H3 and Foundation Medicine will continue to build upon the progress the two companies have made during the collaboration. The companies will collaborate to interrogate the FoundationCORE dataset,