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
Made Scientific has acquired an 85,000ft² cell therapy manufacturing facility in Pennsylvania, US, from National Resilience, adding an operational site to its US East Coast network.
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