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Regulatory news: Nulibry (fosdenopterin) approved to reduce the risk of mortality in patients with molybdenum cofactor deficiency type A: FDA approval summary.
Farrell S, Karp J, Hager R, Wang Y, Adeniyi O, Wang J, Li L, Ma L, Peretz J, Summan M, Kong N, White M, Pacanowski M, Price D, Filie J, Donohue K, Joffe H. Farrell S, et al. Among authors: joffe h. J Inherit Metab Dis. 2021 Sep;44(5):1085-1087. doi: 10.1002/jimd.12421. Epub 2021 Aug 8. J Inherit Metab Dis. 2021. PMID: 34337775 Review. No abstract available.
FDA approval of paroxetine for menopausal hot flushes.
Orleans RJ, Li L, Kim MJ, Guo J, Sobhan M, Soule L, Joffe HV. Orleans RJ, et al. N Engl J Med. 2014 May 8;370(19):1777-9. doi: 10.1056/NEJMp1402080. N Engl J Med. 2014. PMID: 24806158 Free article. No abstract available.
FDA Approval of Flibanserin--Treating Hypoactive Sexual Desire Disorder.
Joffe HV, Chang C, Sewell C, Easley O, Nguyen C, Dunn S, Lehrfeld K, Lee L, Kim MJ, Slagle AF, Beitz J. Joffe HV, et al. N Engl J Med. 2016 Jan 14;374(2):101-4. doi: 10.1056/NEJMp1513686. Epub 2015 Dec 9. N Engl J Med. 2016. PMID: 26649985 Free article. No abstract available.
Testosterone and "Age-Related Hypogonadism"--FDA Concerns.
Nguyen CP, Hirsch MS, Moeny D, Kaul S, Mohamoud M, Joffe HV. Nguyen CP, et al. N Engl J Med. 2015 Aug 20;373(8):689-91. doi: 10.1056/NEJMp1506632. N Engl J Med. 2015. PMID: 26287846 Free PMC article. No abstract available.
FDA Regulation of Prescription Drugs.
Gassman AL, Nguyen CP, Joffe HV. Gassman AL, et al. N Engl J Med. 2017 Feb 16;376(7):674-682. doi: 10.1056/NEJMra1602972. N Engl J Med. 2017. PMID: 28199811 Review. No abstract available.
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). Hicks KA, et al. Among authors: joffe hv. Circulation. 2018 Feb 27;137(9):961-972. doi: 10.1161/CIRCULATIONAHA.117.033502. Circulation. 2018. PMID: 29483172 Review.
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). Hicks KA, et al. Among authors: joffe hv. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048. J Am Coll Cardiol. 2018. PMID: 29495982 Free article. Review.
334 results