FDA Commissioner Martin Makary and Center for Biologics Evaluation and Research Director Vinay Prasad recently published an article in the New ...
The CNPV pilot program significantly reduces review times, but may challenge safety standards and resource allocation.
The CNPV pilot program reduces review times from 10-12 months to 1-2 months, benefiting generics and biosimilars. Companies must align market access, manufacturing, and post-approval readiness with ...
Shimadzu Medical Systems USA (SMS), a division of Shimadzu Precision Instruments, Inc. (SPI) which is fully owned by Shimadzu Corporation, Japan, is excited to announce the release of the MobileDaRt ...
The Woodlands, an exclusive gated enclave of 24 newly constructed townhomes in Demarest, NJ, is posting record sales results for the community ? with multiple closings above the $3.0 million mark and ...
Shaw said Biocon’s growth trajectory over the next five years will be “very exciting,” with even larger opportunities emerging beyond 2030 as big-ticket biologics go off patent.
Biocon is entering a transformative phase, leveraging regulatory shifts in the US and a strong insulin and GLP-1 portfolio to ...
NEW HAMPSHIRE parents never dreamed their kids would face this in school: biological boys in girls’ private spaces and ...
The first wave of Commissioner’s National Priority Vouchers signals a fundamental shift in FDA competitiveness, rewarding companies that pair breakthrough science with affordability commitments, ...
Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for ...
Strategic Hire Strengthens Late Phase and Commercial Readiness as Elicio Advances Lymph Node-Targeted Immunotherapy ...