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February 20, 2024
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
February 16, 2024
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
February 15, 2024
BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.
The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.
February 12, 2024
Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.
The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.
February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 08, 2024
Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.