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Tesamorelin Peptide: Research in Weight Regulation
05 Apr 2024 20:12 GMT
… analyses of randomized controlled trials, including HIV-positive … #47;www.accessdata.fda.gov/drugsatfda_docs/n … (2015). Predictors of Treatment Response to Tesamorelin, a Growth Hormone-Releasing … A randomized, placebo-controlled trial. PLOS ONE. 12(6 …
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Theratechnologies’ HIV Therapy Trogarzo Denied FDA Review
28 Feb 2024 13:44 GMT
… the intramuscular injection could sustain drug levels above the therapeutic threshold … October 2022 for the intravenous treatment of heavily pretreated HIV-1 … , the FDA declined to approve the biotech’s F8 formulation for tesamorelin, which …
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Theratechnologies Gets FDA Rejection for Concentrated Formulation of Tesamorelin
24 Jan 2024 18:46 GMT
… formulation of tesamorelin, which the Canadian biotech was proposing to … drug as well as the final reconstituted product.
The FDA … simplify treatments for people with HIV,” Marsolais said.
Tesamorelin is … is the only FDA-approved treatment to cut abdominal fat …
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Theratechnologies handed CRL for lipodystrophy drug for HIV patients due to CMC issues
24 Jan 2024 17:56 GMT
… the FDA for the more concentrated version of its marketed lipodystrophy drug … .
The F8 formulation of tesamorelin was rejected due to concerns … impurities, microbiology and stability. The FDA also asked for further information …
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Theratechnologies Receives Complete Response Letter (CRL) from the FDA for the F8 Formulation of Tesamorelin sBLA
24 Jan 2024 12:00 GMT
… F4 formulation of tesamorelin, the only medication approved in the U … U.S. Food and Drug Administration (FDA) has issued a Complete … to innovate and simplify treatments for people with HIV.” … ;benefit of continuation of treatment in patients who have …
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sBLA for New Formulation of Tesamorelin Issued Complete Response Letter by FDA
25 Jan 2024 20:07 GMT
… vice president and chief medical officer at Theratechnologies, said … to innovate and simplify treatments for people with HIV … reconstituted drug product, according to Theratechnologies. Further, the FDA … from the FDA for the F8 Formulation of Tesamorelin sBLA. …
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FDA denies approval for Theratechnologies’ tesamorelin F8
25 Jan 2024 11:21 GMT
… Drug Administration (FDA), denying approval for its F8 formulation of tesamorelin … that meet unmet medical needs.
Theratechnologies senior … vice-president and chief medical officer Christian Marsolais … innovate and simplify treatments for people with HIV …
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Theratechnologies Says FDA Needs More Time To Decide On Tesamorelin F8 SBLA
23 Jan 2024 14:06 GMT
… the U.S. Food and Drug Administration (FDA) on its supplemental Biologics … concentrated formulation, of tesamorelin.
A decision from the FDA was expected on … review the application.
Tesamorelin is the only medication approved in the U …
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Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
23 Jan 2024 12:30 GMT
… the F8 formulation of tesamorelin. The FDA has notified the Company that … the application beyond the Prescription Drug User Fee Act (PDUFA) goal … of innovative therapies addressing unmet medical needs. Further information about Theratechnologies …
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FDA rejects Theratechnologies application, with problems 'largely' centered on manufacturing
24 Jan 2024 17:07 GMT
… down a rejection.
The FDA issued a Complete Response Letter … company said Wednesday.
Tesamorelin is the only drug in the U. … from the FDA for the F8 formulation of tesamorelin containing questions … company's chief medical officer, Christian Marsolais, Ph.D …