Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-10-29FDA Approved: STOBOCLO — Original Application (CELLTRION USA, Inc.)
FDA approved STOBOCLO (denosumab-BMWO) from Celltrion USA as an original application; a denosumab biosimilar with indications including oste…
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EMA approval · 2025-10-22EMA Authorised: Prolia (denosumab) — Amgen Europe B.V.
The EMA authorised Prolia (denosumab) from Amgen Europe B.V. for osteoporosis, including postmenopausal osteoporosis. The decision date was …
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FDA approval · 2025-10-16FDA Approved: YORVIPATH — Supplemental Application (Ascendis Pharma, Endocrinology, Inc.)
The FDA approved a supplemental application for YORVIPATH (palopegteriparatide) from Ascendis Pharma Endocrinology, Inc. The approval indica…
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EMA approval · 2025-10-10EMA Authorised: Teriparatide Sun (teriparatide) — Sun Pharmaceutical Industries Europe B.V.
The EMA authorised Teriparatide Sun for osteoporosis, including postmenopausal osteoporosis.
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EMA approval · 2025-10-09EMA Authorised: Zadenvi (denosumab) — Zentiva k.s.
EMA authorised Zadenvi (denosumab) for osteoporosis, including postmenopausal osteoporosis, with Zentiva k.s. as the marketing authorisation…
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EMA approval · 2025-09-26EMA Authorised: Ibandronic acid Accord (ibandronic acid) — Accord Healthcare S.L.U.
The EMA authorised Accord Healthcare S.L.U.'s ibandronic acid product under a marketing authorization. The approval covers indications relat…
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FDA approval · 2025-09-26FDA Approved: CALCITONIN SALMON — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' original application for Calcitonin Salmon (generic), marking the entry of a generic calcitonin product…
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EMA approval · 2025-09-25EMA Authorised: Zoledronic acid Teva (zoledronic acid) — Teva B.V.
The EMA authorised Teva B.V.'s Zoledronic acid product for bone-related conditions and cancer-related bone disease. The active substance is …
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FDA approval · 2025-09-16FDA Approved: BOSAYA — Original Application (Biocon Biologics Inc.)
FDA approved BOSAYA (denosumab-kyqq) from Biocon Biologics Inc. under an Original Application as a biosimilar to denosumab products, with th…
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FDA approval · 2025-08-29FDA Approved: BILPREVDA — Original Application (Organon LLC)
FDA approved Bilprevda (denosumab) under an original Biologics License Application by Organon LLC.
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EMA approval · 2025-08-11EMA Authorised: Zometa (zoledronic acid;zoledronic acid monohydrate) — Phoenix Labs Unlimited Company
The EMA has authorised Zometa (zoledronic acid) for cancer and bone-related indications, with Phoenix Labs Unlimited Company as the marketin…
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FDA approval · 2025-05-30FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, authorizing changes to the drug's labeling. This acti…
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FDA approval · 2025-05-22FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for Prolia (denosumab) submitted by Amgen, Inc.
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EMA approval · 2025-05-07EMA Authorised: Evenity (romosozumab) — UCB Pharma S.A.
The European Medicines Agency authorised Evenity (romosozumab) from UCB Pharma S.A. for the treatment of osteoporosis, with decision dated 0…
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FDA approval · 2025-03-28FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)
FDA approved a supplemental application for TYMLOS (abaloparatide) by Radius Health, Inc. The approval expands the product's labeling for os…
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FDA approval · 2025-02-28FDA Approved: STOBOCLO — Original Application (CELLTRION USA, Inc.)
FDA approved STOBOCLO (denosumab-BMWO) from Celltrion USA under an original Biologics License Application for multiple osteoporosis and canc…
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FDA approval · 2025-01-24FDA Approved: TERIPARATIDE — Supplemental Application (Alvogen, Inc.)
The FDA approved a supplemental application for teriparatide submitted by Alvogen, Inc. This action updates the drug's labeling.
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EMA approval · 2024-11-25EMA Authorised: Kauliv (teriparatide) — Strides Pharma (Cyprus) Limited
The EMA has authorized Kauliv, a teriparatide-containing medicine by Strides Pharma (Cyprus) Limited, for osteoporosis and postmenopausal os…
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FDA approval · 2024-11-07FDA Approved: TERIPARATIDE — Supplemental Application (Apotex Corp.)
FDA approves Apotex Corp.'s supplemental application for a generic teriparatide product.
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FDA approval · 2024-11-06FDA Approved: TERIPARATIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for Teriparatide (teriparatide), enabling marketing of a generic teriparatide product. This act…
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FDA approval · 2024-09-27FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM by Aurobindo Pharma Limited (generic).
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EMA approval · 2024-09-16EMA Authorised: Bonviva (ibandronic acid) — Atnahs Pharma Netherlands B.V.
The EMA authorised Bonviva (ibandronic acid) for osteoporosis, including postmenopausal osteoporosis. The marketing authorization holder is …
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FDA approval · 2024-08-09FDA Approved: YORVIPATH — Original Application (Ascendis Pharma, Endocrinology, Inc.)
FDA approved Yorvipath (palopegteriparatide) in an original NDA from Ascendis Pharma, Endocrinology, Inc. (NDA216490).
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FDA approval · 2024-07-24FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, enabling regulatory clearance of the teriparatide…
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EMA approval · 2024-04-12EMA Authorised: Eladynos (abaloparatide) — Theramex Ireland Limited
EMA has authorised Eladynos (abaloparatide) for osteoporosis, including postmenopausal osteoporosis, with Theramex Ireland Limited as the MA…