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FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.
Dilawari A, Shah M, Ison G, Gittleman H, Fiero MH, Shah A, Hamed SS, Qiu J, Yu J, Manheng W, Ricks TK, Pragani R, Arudchandran A, Patel P, Zaman S, Roy A, Kalavar S, Ghosh S, Pierce WF, Rahman NA, Tang S, Mixter BD, Kluetz PG, Pazdur R, Amiri-Kordestani L. Dilawari A, et al. Among authors: patel p. Clin Cancer Res. 2023 Oct 2;29(19):3835-3840. doi: 10.1158/1078-0432.CCR-23-0991. Clin Cancer Res. 2023. PMID: 37212825 Free PMC article.
FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.
Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R. Shah A, et al. Among authors: patel p. Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7. Clin Cancer Res. 2018. PMID: 29437768
FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.
Krauss AC, Gao X, Li L, Manning ML, Patel P, Fu W, Janoria KG, Gieser G, Bateman DA, Przepiorka D, Shen YL, Shord SS, Sheth CM, Banerjee A, Liu J, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R. Krauss AC, et al. Among authors: patel p. Clin Cancer Res. 2019 May 1;25(9):2685-2690. doi: 10.1158/1078-0432.CCR-18-2990. Epub 2018 Dec 12. Clin Cancer Res. 2019. PMID: 30541745 Clinical Trial.
FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Przepiorka D, Le RQ, Ionan A, Li RJ, Wang YH, Gudi R, Mitra S, Vallejo J, Okusanya OO, Ma L, Yang Y, Patel P, Mezaache D, Shah R, Banerjee A, McLamore S, Maung AN, Goldberg KB, Pazdur R, Theoret MR, De Claro RA. Przepiorka D, et al. Among authors: patel p. Clin Cancer Res. 2022 Jun 13;28(12):2488-2492. doi: 10.1158/1078-0432.CCR-21-4176. Clin Cancer Res. 2022. PMID: 35135839 Free PMC article.
FDA/M-CERSI Co-Processed API Workshop Proceedings.
Schenck L, Patel P, Sood R, Bonaga L, Capella P, Dirat O, Erdemir D, Ferguson S, Gazziola C, Gorka LS, Graham L, Ho R, Hoag S, Hunde E, Kline B, Lee SL, Madurawe R, Marziano I, Merritt JM, Page S, Polli J, Ramanadham M, Sapru M, Stevens B, Watson T, Zhang H. Schenck L, et al. Among authors: patel p. J Pharm Sci. 2023 Aug;112(8):2069-2078. doi: 10.1016/j.xphs.2023.01.006. Epub 2023 Jan 10. J Pharm Sci. 2023. PMID: 36638959
Characterization of Biologic Discontinuation Among Pediatric Patients with Crohn's Disease.
Ali S, Pasternak B, Moses J, Suskind DL, Samson C, Kaplan J, Creps J, Manning L, Baker M, Singer D, Patel P, Trombler B, Anandakrishnan A, Khorrami C, Feldman M, McGoldrick M, Adler J. Ali S, et al. Among authors: patel p. Clin Gastroenterol Hepatol. 2024 May 7:S1542-3565(24)00406-3. doi: 10.1016/j.cgh.2024.03.043. Online ahead of print. Clin Gastroenterol Hepatol. 2024. PMID: 38723980
The Association of Urinary Sodium Excretion with Glaucoma and Related Traits in a Large United Kingdom Population.
Stuart KV, Biradar MI, Luben RN, Dhaun N, Wagner SK, Warwick AN, Sun Z, Madjedi KM, Pasquale LR, Wiggs JL, Kang JH, Lentjes MAH, Aschard H, Kim J, Foster PJ, Khawaja AP; Modifiable Risk Factors for Glaucoma Collaboration, the UK Biobank Eye and Vision Consortium, and the International Glaucoma Genetics Consortium. Stuart KV, et al. Ophthalmol Glaucoma. 2024 May 7:S2589-4196(24)00074-7. doi: 10.1016/j.ogla.2024.04.010. Online ahead of print. Ophthalmol Glaucoma. 2024. PMID: 38723778
Pegcetacoplan Treatment and Consensus Features of Geographic Atrophy Over 24 Months.
Fu DJ, Bagga P, Naik G, Glinton S, Faes L, Liefers B, Lima R, Wignall G, Keane PA, Ioannidou E, Ribeiro Reis AP, McKeown A, Scheibler L, Patel PJ, Moghul I, Pontikos N, Balaskas K. Fu DJ, et al. Among authors: patel pj. JAMA Ophthalmol. 2024 May 9. doi: 10.1001/jamaophthalmol.2024.1269. Online ahead of print. JAMA Ophthalmol. 2024. PMID: 38722644
8,415 results