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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
Armed with positive results from two late-stage studies, Germany’s Novaliq has submitted a New Drug Application (NDA) to the FDA for its novel treatment for dry eye disease. Read More