Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-11-16FDA Approved: TERIPARATIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s generic teriparatide through an original ANDA for use in osteoporosis.
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FDA label_change · 2023-10-27FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp)
The FDA approved a supplemental application for ibandronate sodium from Apotex Corp, typically indicating a labeling modification under the …
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CLINICAL_TRIALS trial_result · 2023-10-26Clinical Trial Update: Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities [Phase 2, Phase 3]
Clinical trial update on secondary prevention of osteoporotic fractures in long-term care residents, spanning Phase 2 and Phase 3, status co…
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CLINICAL_TRIALS trial_result · 2023-10-25Clinical Trial Update: The Optimised Use of Romozosumab Study [Phase 4]
A Phase 4 clinical trial updating the optimized use of Romozosumab in osteoporosis is currently recruiting.
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CLINICAL_TRIALS trial_result · 2023-10-13Clinical Trial Update: Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis [Phase 3]
Phase 3 clinical trial update for a denosumab biosimilar injected in postmenopausal women with osteoporosis.
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CLINICAL_TRIALS trial_result · 2023-10-12Clinical Trial Update: Testosterone and Alendronate in Hypogonadal Men [Phase 2]
Phase 2 trial update on testosterone and alendronate in hypogonadal men with osteopenia; study terminated with results posted.
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CLINICAL_TRIALS trial_result · 2023-10-11Clinical Trial Update: Efficacy and Safety of MW031 in PMO Subjects [Phase 3]
Phase 3 trial update on MW031 for osteoporosis in postmenopausal patients completed, reporting efficacy and safety results.
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University. [Phase 3]
Phase 3 trial evaluating soy isoflavone effects on bone health in Saudi female students has completed.
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FDA approval · 2023-08-24FDA Approved: ESTRADIOL — Original Application (NorthStar Rx LLC)
FDA approved NorthStar Rx LLC's Estradiol as an original-application generic product (ANDA217610).
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CLINICAL_TRIALS research · 2023-08-22Clinical Trial Update: Prevention of Post Operative Bone Loss in Children [NA]
Clinical trial on prevention of postoperative bone loss in children completed, with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-08-09Clinical Trial Update: Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease [Phase 4]
Phase 4 trial evaluating denosumab on bone and vascular metabolism in osteoporotic chronic kidney disease; the study status is terminated.
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FDA approval · 2023-06-23FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for ibandronate sodium submitted by Apotex Corp as part of an ANDA, representing a regulatory update…
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FDA approval · 2023-06-07FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for ibandronate sodium from Macleods Pharmaceuticals Limited. This approval constitutes a supplement…
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CLINICAL_TRIALS trial_result · 2023-06-07Clinical Trial Update: Comparative Antiresorptive Efficacy Discontinuation of Denosumab [Phase 4]
A Phase 4 trial update on discontinuation of denosumab evaluating antiresorptive efficacy in osteoporosis conditions may influence managemen…
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FDA approval · 2023-06-07FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for risendronate sodium from Macleods Pharmaceuticals Limited.
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FDA approval · 2023-06-06FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM from Aurobindo Pharma Limited, enabling the approved generic formulation to b…
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FDA approval · 2023-06-05FDA Approved: ZOLEDRONIC ACID — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' original application for zoledronic acid, enabling a generic IV bisphosphonate product. This mark…
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CLINICAL_TRIALS trial_result · 2023-05-15Clinical Trial Update: Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too! [NA]
A completed clinical trial evaluating breastfeeding and exercise for healthy infants and postpartum moms; conditions include osteoporosis, o…
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FDA approval · 2023-05-12FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for risendronate sodium (a generic osteoporosis medication) under ANDA090877.
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FDA approval · 2023-05-11FDA Approved: ALENDRONATE SODIUM — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' Original Application (ANDA) for alendronate sodium (ALENDRONATE SODIUM).
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CLINICAL_TRIALS trial_result · 2023-05-09Clinical Trial Update: Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss [Phase 4]
Phase 4 trial update on Pearlium®/Effecti-Cal®, a calcium, vitamin D and minerals formulation for prevention of postmenopausal bone loss.
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FDA label_change · 2023-04-28FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for risedronate sodium, resulting in updated labeling. This …
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FDA approval · 2023-04-28FDA Approved: ESTRADIOL VALERATE — Original Application (Xiromed, LLC)
The FDA approved Xiromed, LLC's Estradiol Valerate as an original-application generic (ANDA 216656), authorizing its marketing for approved …
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CLINICAL_TRIALS trial_result · 2023-04-13Clinical Trial Update: Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid [Phase 4]
Phase 4 clinical trial investigating how dermocorticoids affect bone mineral density in patients with bullous pemphigoid, with osteoporosis …
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CLINICAL_TRIALS trial_result · 2023-04-07Clinical Trial Update: Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) [Phase 3]
Phase 3 trial update on abaloparatide-SC in men with osteoporosis completed; results posted in 2023.