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FDA Type C meeting minutes provide clarity on the Phase 2/3 study design for RAD011 505(b)(2) regulatory strategy: acceptable approach upon completion of PK & food effect studies Based on results, a single well controlled study could serve as the basis for marketing approval RAD011 had previously
WALTHAM, Mass. , Dec. 19, 2014 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for its investigational drug RAD1901, a tissue-selective estrogen receptor
TYMLOS is the first new anabolic (bone building) agent for postmenopausal women with osteoporosis in the United States in nearly 15 years US Commercial Launch in May Approval Based on Results at 18 months from the Landmark ACTIVE Trial and the first six months of ACTIVExtend Trial Nearly One in Two
WALTHAM, Mass., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) today announced that Fractured Truth—an unbranded patient campaign aimed to educate younger postmenopausal women about risks associated with osteoporosis—won the Bronze Healthcare/Pharmaceutical Industry Pearl
Radius Health announces positive Phase 3 data from the ACTIVExtend trial presented at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting First six months of top-line data from ACTIVExtend show that treatment with investigational drug abaloparatide-SC followed by
Results from Phase 3 ACTIVE trial show abaloparatide significantly reduced the incidence of new vertebral fractures and nonvertebral fractures in postmenopausal women with osteoporosis at 18 months when compared with placebo
— Results from interim analysis of the ACTIVExtend study of postmenopausal women with osteoporosis treated for 18 months with investigational drug abaloparatide-SC in the ACTIVE trial who were transitioned to alendronate in ACTIVExtend show statistically significant reductions at six months in the
Menarini licenses global development and commercialization rights of elacestrant, an oral SERD currently in late stage Phase 3 development Elacestrant further strengthens Menarini’s global oncology portfolio, recently bolstered by the acquisition of Stemline Therapeutics in the U.S.
Study met both primary endpoints in patients with ER+/HER2- advanced or mBC Elacestrant becomes the first oral SERD with positive topline results in pivotal study as a monotherapy versus SoC for the treatment of ER+/HER2- advanced or mBC Elacestrant extended PFS in the overall population and the
The data was presented in an Oral Late-Breaker at Annual Endocrine Society Meeting "ENDO 2017" on April 1 Additional analysis of BMD gains at the wrist and fracture reductions at the ultradistal radius compared to placebo and teriparatide were presented on April 2 WALTHAM, Mass., April 03, 2017