The US Food and Drug Administration (FDA) has granted approval for Radius Health’s Tymlos (abaloparatide) to boost bone density in men with osteoporosis at increased fracture risk.
Tokyo, Japan, September 5, 2022 --- Teijin Pharma Limited, the core company of the Teijin Group's healthcare business, announced today that on August 31 the company obtained manufacturing and sales approval from Japan's Ministry of Health, Labour and Welfare for its abaloparatide acetate treatment OSTABALO® Subcutaneous Injection Cart 1.5mg. The newly approved specification, which is for the treatment of osteoporosis, is expected to help promote bone formation in patients with high risk of bone fractures.
Company ascertained regulatory clarity for possible forward progression of abalo-TDSAdditional and successful clinical trial would be required to advance towards an NDA filingNew timeline for earliest...
BOSTON, Dec. 23, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) today announced that the U.S. Food and Drug Administration (FDA) has approved updates to the TYMLOS label, including the removal of the boxed warning regarding the risk of osteosarcoma.
BOSTON, Dec. 23, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) today announced that the U.S. Food and Drug Administration (FDA) has approved updates to the TYMLOS label, including the removal of the boxed warning regarding the risk of osteosarcoma.
BOSTON, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS), today announced positive topline results from the ATOM study evaluating abaloparatide 80mcg subcutaneous (SC) for use in males with osteoporosis.
DUBLIN, Jan. 5, 2021 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today that its subsidiary Endo Ventures Limited has entered into definitive agreements with Radius Health, Inc. (NASDAQ: RDUS) to register, commercialize and distribute abaloparatide on an exclusive basis in Canada. Paladin Labs Inc., an operating company of Endo, will be responsible for all commercial activities related to abaloparatide. Under the agreement, Endo obtained the rights to abaloparatide-subcutaneous injection (abaloparatide-SC) and abaloparatide-transdermal patch (abaloparatide-TD), a novel formulation and route of administration currently undergoing clinical development.
Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced completion of enrollment in its “wearABLe” phase 3 trial.
WALTHAM, Mass., May 27, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS), today announced that its partner, Teijin Pharma Limited, has submitted a New Drug Application for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are at high risk for fractures.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday adopted a negative opinion for UCB Pharma’s osteoporosis treatment Evenity (romosozumab), which was approved by the US Food and Drug Administration (FDA) in April.