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Human medicines European public assessment report (EPAR): Xoanacyl, ferric citrate coordination complex, Status: Opinion
28 Mar 2025 14:56 GMT
… for the medicinal product Xoanacyl, intended for the treatment of concomitant … studied in two clinical trials in patients with CKD … be non-inferior to sevelamer carbonate in reducing serum … is indicated for the treatment of concomitant elevated serum …
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Comprehensive Analysis of the Global Hypercalcemia Treatment Market: Trends, Growth Drivers, and Forecast 2025-2034
26 Mar 2025 17:50 GMT
… advancements in treatment, innovative ground-breaking drugs for hypercalcemia treatment, and prevalent … Inc., Ferring Pharmaceuticals A/S, Rockwell Medical Inc., Strides … States Food and Drug Administration FDA for its Sevelamer Carbonate Tablets, 800 …
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FDA-approved dialysis drug may help fight against antimicrobial resistance
18 Mar 2025 22:11 GMT
… Food and Drug Administration (FDA)-approved drug sevelamer, typically prescribed … treatments for primary infections or develop primary infections after a medical … Eberly Professor of Biotechnology and co-author … who earned his doctorate in chemical engineering …
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ANDA Approvals - New Drug Applications and 505(b)(2) Applications: Third Quarter
15 Nov 2024 22:16 GMT
Approval Date
Reference Listed Drug
Generic Drug Name
NDA Holder
…
Endari
L-Glutamine
Emmaus Medical
Novitium Pharma
215647
07… ;12/2024
Renvela
Sevelamer Carbonate
Sanofi Genzyme
InvaGen …
Tarceva
Erlotinib HCl
OSI Pharmaceuticals
Hikma
203843
09…
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FDA Approved Drug Products Approval List July 2024
08 Aug 2024 12:44 GMT
… 3 SOMATROGON-GHLA PFIZER IRELAND PHARMACEUTICALS Approval 07… SUPPL-17 APALUTAMIDE JANSSEN BIOTECH Manufacturing (CMC) Approval 07 … 47;2024 SEVELAMER CARBONATEANDA #206234 ORIG-1 SEVELAMER CARBONATE INVAGEN … 47;31/2024 MEDICAL AIR, USPNDA #219709 …
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Ardelyx Announces Publication of Two Plain Language Summaries from XPHOZAH® (tenapanor) Clinical Trials in Current Medical Research and Opinion
31 Jul 2024 12:02 GMT
… trials on XPHOZAH® (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical … trial from both the XPHOZAH arm and the sevelamer … added to their treatment regimen while reducing sevelamer tablets based … in Japan. A New Drug Application for tenapanor for …
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Sucroferric Oxyhydroxide Effectively Controls Serum Phosphorus and Reduces Phosphate Binder Pill Burden in Patients on Peritoneal Dialysis
25 Jul 2024 01:17 GMT
… 91-day intervals of SO treatment.
The results showed that among … others switched to SO from sevelamer (39.7%), calcium acetate ( … 54.0%. The average PB pills per day dropped from 7 … in managing sP while reducing pill burden.
Source: bmcnephrol.biomedcentral. …
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Ardelyx sues CMS over revamped kidney disease drug payment bundle
18 Jul 2024 19:46 GMT
… available for Medicare beneficiaries. The ESRD PPS adjusts treatment costs at …
The US Food and Drug Administration (FDA) approved Xphozah to reduce … include Takeda Pharmaceuticals’ Fosrenol (lanthanum carbonate) and Genzyme’s Renvela (sevelamer), which …
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Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)
10 Jul 2024 11:03 GMT
… 5) pills per day. On OLC, the pill burden at … the availability of several FDA-cleared medications, 75 percent of … biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug … of future trial results; our clinical trials may be …
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Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial
25 Jun 2024 11:30 GMT
… pill burden for patients in terms of number and size of pills … of several FDA-cleared medications, 75 percent … biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug … future trial results; our clinical trials may …
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