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HOPA 2025: Understanding the Recent Changes for 505(b)(2) Drugs and Reimbursement
12 Apr 2025 02:27 GMT
… shifting Centers for Medicare & Medicaid Services (CMS) …
The FDA Approval Process
Within the FDA approval … drugs that have been approved through this pathway include albumin-bound paclitaxel … pharmaceutical companies then pushed to get their 505(b)(2) drugs …
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Cipla’s generic drug for cancer gets U.S. FDA nod
11 Apr 2025 19:40 GMT
Cipla’s abbreviated new drug application for a … Myers Squibb’s cancer drug Abraxane has received final … Food and Drug Administration.
The final approval for Paclitaxel Protein-bound … .
Protein-bound Paclitaxel is indicated for treatment of metastatic breast …
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Paclitaxel-coated Balloon Dilation for Urethral Stricture Disease: 5 Years of Clinical Insights and Future Directions for Optilume.
11 Apr 2025 18:00 GMT
The Optilume drug-coated balloon is a promising advance for minimally invasive treatment of urethral stricture, with encouraging mid-term results. Further studies are needed to assess its long-term durability, particularly in off-label applications and …
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Breast Cancer Treatment in Germany: New Therapies, Doctors, and Results in 2025
09 Apr 2025 20:40 GMT
… effective treatment options. Through a combination of high medical standards … centers.
Antibody-Drug Conjugates (ADCs)
Antibody-drug conjugates are … such as nab-paclitaxel and have shown … participating in clinical trials exploring immunotherapy combinations …
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Cipla cancer generic receives FDA final nod
11 Apr 2025 15:13 GMT
… Food and Drug Administration (FDA) final approval for its Protein-bound Paclitaxel, a … , is “Abbreviated New Drug Application (‘ANDA’) submitted for Paclitaxel Protein-bound Particles … ’s Abraxane, indicated for the treatment of metastatic breast cancer, non …
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Gold@Mesoporous Polydopamine Nanocomposite Hydrogel Loaded with Estrogen for the Treatment of Skin Photoaging
11 Apr 2025 12:53 GMT
… Medical University(approval number: wydw2024-0556).
Grouping and Treatment … animal experiments and clinical trials, while exploring its … doi:10.3390/pharmaceutics16101332
18. Ibrahim B, … complex loaded with drug paclitaxel hydrogels against thyroid cancer …
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Cipla Limited receives USFDA final approval for ANDA Protein-bound Paclitaxel
11 Apr 2025 12:46 GMT
… the United States Food and Drug Administration ('USFDA… New Drug Application ('ANDA') submitted for Paclitaxel Protein … Vial ('Protein-bound Paclitaxel') on 10th April, … Protein-bound Paclitaxel is indicated for the treatment of metastatic …
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Latest News | Cipla Gets USFDA Nod for Generic Cancer Drug
11 Apr 2025 07:10 GMT
… to market a generic cancer treatment drug.
The company has received the … the Abbreviated New Drug Application (ANDA) submitted for paclitaxel protein-bound particles … ;vial.
Protein-bound paclitaxel is indicated for the treatment of metastatic breast …
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Study Provides Scaffold to Selectively Target Drug Breakdown Process
11 Apr 2025 02:55 GMT
… drugs that treat various health conditions, including the anti-cancer agent paclitaxel … for mild COVID-19 treatment. However, such CYP3A4 … National Institute of General Medical Sciences (R35GM118041) and … it makes to help doctors and researchers at local …
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FDA Approves Avastin Biosimilar Jobevne Across Several Cancer Types
10 Apr 2025 20:04 GMT
… : study of how the drug is absorbed, distributed, metabolized … cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
Additionally … treatment. Biosimilars, the FDA notes on its website, can increase access to lifesaving medications …