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Theratechnologies Receives FDA Approval of Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA
08 Apr 2025 11:00 GMT
… the U.S. Food and Drug Administration (FDA) has approved the Company … SV® (tesamorelin for injection). Tesamorelin for injection is the only treatment approved in … side effects of prescription drugs to the FDA. Visit http:/…
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Clinical Insights on HIV-Associated Visceral Fat Following FDA Approval of Tesamorelin F8
26 Mar 2025 13:48 GMT
… , MD, professor of medicine in the Division of … was skinny because the medicines also wasted subcutaneous fat. … differs from general adiposity treatment strategies. "Diet … . Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to …
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FDA Approves F8 Formulation of Theratechnologies' Tesamorelin for HIV-Associated Lipodystrophy
25 Mar 2025 23:48 GMT
… (sBLA) for EGRIFTA WR (Tesamorelin F8), a treatment for excess visceral abdominal … , senior vice president and chief medical officer at Theratechnologies, he said … Complete Response Letter (CRL). The FDA concluded that the updated formulation …
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Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
25 Mar 2025 21:45 GMT
… U.S. Food and Drug Administration (FDA) has approved the … WR™. Tesamorelin for injection is the only medication approved in … conveniently dosed formulation of tesamorelin is a welcome advancement.” … ;benefit of continuation of treatment in patients who have …
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FDA Action Alert: GSK, Alnylam, Sanofi and More
10 Mar 2025 21:08 GMT
… FDA decisions this month is for Alnylam Pharmaceuticals, … FDA’s concerns and provided additional data regarding tesamorelin’s immunogenicity risk.
Tesamorelin … biotech is developing for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA …
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Rising HIV Prevalence Fuels Growth In The Industry: Transforming The Egrifta (Tesamorelin Acetate) Market In 2025
05 Mar 2025 12:25 GMT
… of treatments into comprehensive healthcare plans.
o Expansion of personalized medicine strategies … Drug Administration (FDA).
How is the Egrifta Tesamorelin Acetate Market Segmented?
The Egrifta Tesamorelin …
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Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review
26 Nov 2024 12:30 GMT
… simplified dosing for the treatment of excess abdominal fat … Drug Administration (FDA) for the F8 formulation of tesamorelin, the only medication … ;benefit of continuation of treatment in patients who have … or has had radiation treatment to their head or …
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FDA Decisions to Watch Q1-Q2: Infectious Disease
28 Jan 2025 23:03 GMT
… an antibiotic for the treatment of uncomplicated urinary tract … is an issue.4
Tesamorelin F8
PDUFA Date: March … date TBD)
Company: Theratechnologies
Tesamorelin F8 is a growth hormone … Nordic. Bavarian Nordic announces FDA acceptance and priority review of …
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Tesamorelin’s Impact on Neurocognitive Function and Waist Circumference
22 Jan 2025 13:18 GMT
… summary of “Effects of Tesamorelin on Neurocognitive Impairment in Abdominally … retrospective study to investigate whether tesamorelin, a growth hormone-releasing … to SOC.
Investigators concluded the tesamorelin treatment effectively reduced WC, and it …
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Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA
10 Dec 2024 20:15 GMT
… the United States Food and Drug Administration (FDA) has assigned a Prescription … F8 formulation of tesamorelin. If approved by the FDA, the F8 formulation … of innovative therapies addressing unmet medical needs. Further information about Theratechnologies …