Bone Metastases
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-11-06EMA Authorised: Quadramet (samarium (153Sm) lexidronam pentasodium) — CIS bio international
EMA authorised Quadramet (samarium-153 lexidronam pentasodium) for the palliation of bone pain in cancer patients with bone metastases.
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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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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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EMA approval · 2024-09-16EMA Authorised: Bondronat (ibandronic acid) — Atnahs Pharma Netherlands B.V.
EU marketing authorisation granted to Bondronat (ibandronic acid) for hypercalcemia, breast cancer with bone metastases, and bone-related fr…
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FDA approval · 2023-03-08FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for zoledronic acid from Fresenius Kabi USA, LLC.
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FDA approval · 2023-03-07FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for zoledronic acid submitted by Mylan Institutional LLC.
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FDA approval · 2022-04-05FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
The FDA approved a supplemental application for Zoledronic acid submitted by Sagent Pharmaceuticals, updating regulatory labeling per the su…
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EMA approval · 2020-11-20EMA Authorised: Zoledronic acid medac (zoledronic acid monohydrate) — medac Gesellschaft für klinische Spezialpräparate mbH
The EMA authorised zoledronic acid monohydrate (Zoledronic acid medac) for use in fractures/bone-related conditions and cancer, under the ma…
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FDA approval · 2020-10-20FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Zoledronic acid from Hikma Pharmaceuticals USA Inc., indicating regulatory approval for the spon…
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FDA approval · 2020-10-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for zoledronic acid from Mylan Institutional LLC under an abbreviated new drug application (ANDA), e…
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FDA approval · 2020-02-21FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for Zoledronic acid from Dr. Reddy's Laboratories Limited, authorizing a generic product through…
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FDA approval · 2020-02-21FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for zoledronic acid submitted by BluePoint Laboratories (ANDA205279).
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FDA approval · 2018-06-29FDA Approved: ZOLEDRONIC ACID — Original Application (Gland Pharma Limited)
The FDA approved an Original Application for a generic zoledronic acid product by Gland Pharma Limited.
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FDA approval · 2016-08-05FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc., signaling an approved modification to its label…
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FDA approval · 2016-07-14FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a supplemental application for a generic zoledronic acid product from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals)…
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FDA approval · 2016-05-19FDA Approved: SODIUM FLUORIDE F 18 — Original Application (Kreitchman PET Center)
FDA approved the original application for Sodium Fluoride F-18 as a radiopharmaceutical for PET bone imaging.
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FDA approval · 2016-03-25FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for zoledronic acid filed by Sagent Pharmaceuticals.
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FDA approval · 2015-11-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Zoledronic Acid from Hikma Pharmaceuticals USA Inc., resulting in a supplemental approval fo…
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FDA approval · 2015-10-19FDA Approved: SODIUM FLUORIDE F 18 — Original Application (3D Imaging Drug Design and Development LLC)
The FDA approved the original application for Sodium Fluoride F-18, an imaging agent for PET bone imaging to help detect bone abnormalities …
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FDA approval · 2015-10-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)
FDA approves a supplemental application for zoledronic acid from BPI Labs LLC under ANDA 202930. This action supports continued availability…
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FDA approval · 2015-09-28FDA Approved: SODIUM FLUORIDE F 18 — Original Application (PETNET Solutions, Inc.)
FDA approved Sodium Fluoride F-18 for PET imaging through an Original Application filed by PETNET Solutions, Inc.
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FDA approval · 2015-09-10FDA Approved: KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Cardinal Health 414, LLC)
FDA approved a supplemental application for the Kit for the Preparation of Technetium Tc-99m Medronate, enabling continued use in preparing …
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FDA approval · 2015-08-18FDA Approved: SODIUM FLUORIDE F 18 — Original Application (SOFIE Co.)
FDA approved Sodium Fluoride F-18 from SOFIE Co. via an Original Application for use as a radiopharmaceutical in PET bone imaging to evaluat…
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FDA approval · 2015-05-27FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)
FDA approved a supplemental application for zoledronic acid from BPI Labs LLC under an ANDA.