SHIJIAZHUANG, China, July 9, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG8 drug ...
Sridevi Khambhampaty, CEO, Shilpa Biologicals Pvt Ltd commented, “The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity and this ADC drug su ...
HLB's hopes of bringing its liver cancer treatment to the US market have suffered another blow after the US Food and Drug ...
Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market for complex biologics, and shore up U.S. medicine ...
Amphastar Pharmaceuticals said one of its subsidiaries received a warning letter from the Food and Drug Administration regarding one of its facilities, citing violations of current good manufacturing ...
HLB's liver cancer drug rivoceranib has again failed to clear the US Food and Drug Administration, receiving a complete ...
SHANGHAI, June 24, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG17 drug substance ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
Shilpa Biologicals says India has the scientific talent and infrastructure to be a trusted partner in ADC drug substance manufacturing.