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An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More
Researchers in Europe used Abbott’s i-STAT TBI (traumatic brain injury) test to show how two blood-based biomarkers can effectively predict the initial outcome of such injuries. Read More
Long-term results from the clinical study that supported the FDA’s approval of Channel Medsystems’ Cerene Cryotherapy system show that the device continued its steady reduction of heavy menstrual bleeding after three years. Read More
Catalent announced that it will shell out $475 million to acquire Metrics Contract Services, a specialty contract development and manufacturing organization (CDMO) with a 333,000 square-foot facility in Greenville. Read More
The FDA slapped Akorn, a sterile drug manufacturer, with a Form 483 over unexplained discrepancies and batch failures following an inspection of its Decatur, Ill., plant conducted from March 28 to April 8. Read More
BeiGene’s anti-PD-1 monoclonal antibody tislelizumab has racked up more positive phase 3 numbers, proving itself just as good as sorafenib in extending the lives of patients with unresectable hepatocellular carcinoma. Read More
Abecma (idecabtagene vicleucel), a first-in-class CAR-T cell treatment codeveloped by Bristol Myers Squibb and 2seventybio, significantly improved progression-free survival relative to standard therapy in patients with relapsed multiple myeloma, the companies reported. Read More