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251,215 Results for "grace science llc".
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FDA
Grace Science, LLC Selected by FDA to Participate in the START Pilot Program for GS-100 Gene Therapy for NGLY1 Deficiency and Announcement of the Successful Treatment of the 2nd Patient
Grace Science, LLC announced today that the IND for GS-100, an AAV9 gene therapy for NGLY1 Deficiency, was accepted into the FDA’s Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.
June 3, 2024
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3 min read
Drug Development
Grace Science, LLC Announces First Patient Treated in Phase 1/2/3 Trial of GS-100, an AAV9 Gene Therapy for NGLY1 Deficiency
Grace Science, LLC announced today that the first patient was dosed in an open-label Phase 1/2/3 clinical trial of GS-100, an AAV9 gene replacement therapy for the treatment of NGLY1 Deficiency.
March 5, 2024
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2 min read
Business
Andelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 Deficiency
Andelyn Biosciences has partnered with Grace Science, LLC, to tech transfer and manufacture GS-100, a suspension process AAV NGLY1 gene therapy for Phase I/II/III clinical trial material for the treatment of NGLY1 Deficiency.
March 25, 2024
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3 min read
Press Releases
Grace Therapeutics to Exhibit at the American Society of Health-System Pharmacists Conference
December 4, 2024
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6 min read
Drug shortages
FDA Confirms Lilly’s GLP-1s Are Not in Shortage, Gives Compounders Grace Period
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
December 19, 2024
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3 min read
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Tristan Manalac
Press Releases
Acasti Announces Corporate Name Change to Grace Therapeutics, Inc.
October 28, 2024
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8 min read
Press Releases
Grace Therapeutics Announces Second Fiscal Quarter 2025 Financial Results, Provides Business Update
November 13, 2024
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13 min read
Drug Development
Grace Science Announces FDA Clearance of Investigational New Drug (IND) Application to Initiate a Phase 1/2/3 Trial for the Treatment of NGLY1 Deficiency with GS-100, an AAV9 NGLY1 Gene Therapy
Grace Science, LLC announced today that it has received FDA clearance of its Investigational New Drug (IND) application for GS-100, an AAV9 gene replacement therapy for the treatment of NGLY1 Deficiency.
November 7, 2023
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2 min read
Drug Development
Corcept Therapeutics Announces Presentations of Results of Pivotal Phase 3 GRACE Trial Evaluating Relacorilant in Patients with Hypercortisolism (Cushing’s Syndrome)
Corcept Therapeutics Incorporated today announced that the results from GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing’s syndrome).
June 3, 2024
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3 min read
Drug Development
Corcept Announces Primary Endpoint Met in Pivotal Phase 3 GRACE Trial of Relacorilant in Patients With Hypercortisolism (Cushing’s Syndrome)
Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced that GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing’s syndrome), met its primary endpoint.
May 28, 2024
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4 min read
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