Cytomegalovirus Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-09-08FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIVTENCITY (maribavir) filed by Takeda Pharmaceuticals America, Inc., indicating an approved…
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FDA approval · 2022-08-22FDA Approved: VALGANCICLOVIR — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for valganciclovir from Ajanta Pharma USA Inc., confirming regulatory approval of a generic valganci…
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FDA approval · 2022-08-18FDA Approved: VALGANCICLOVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for valganciclovir submitted by Camber Pharmaceuticals, Inc.
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FDA approval · 2022-06-29FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)
The FDA approved a supplemental application to Somerset Therapeutics, LLC for valganciclovir hydrochloride (valganciclovir), authorizing a g…
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FDA approval · 2022-06-27FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for valganciclovir hydrochloride by NorthStar Rx LLC. This approval grants a generic formulation…
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FDA approval · 2022-02-17FDA Approved: VALGANCICLOVIR — Original Application (airis PHARMA PVT LTD)
FDA approves the original application for valganciclovir from airis PHARMA PVT LTD, enabling a generic version of the antiviral for cytomega…
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FDA approval · 2022-01-18FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for LIVTENCITY (maribavir) from Takeda Pharmaceuticals America, Inc., authorizing changes to the dru…
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CLINICAL_TRIALS trial_result · 2022-01-04Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor [Phase 2]
Phase 2 trial results assess the efficacy and safety of the ASP0113 CMV vaccine in CMV-seronegative kidney transplant recipients receiving a…
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CLINICAL_TRIALS trial_result · 2021-11-01Clinical Trial Update: Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) [Phase 1]
Phase 1 trial evaluating safety, tolerability, and immunogenicity of the human cytomegalovirus vaccine V160 in healthy adults has been compl…
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CLINICAL_TRIALS trial_result · 2021-07-16Clinical Trial Update: Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients [Phase 2]
Phase 2 trial update for CMX001 in preventing or controlling cytomegalovirus infection in CMV-seropositive hematopoietic stem cell transplan…
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CLINICAL_TRIALS trial_result · 2021-06-02Clinical Trial Update: Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss [Phase 2]
Phase 2 clinical trial evaluating valganciclovir therapy in infants and children with congenital cytomegalovirus infection and hearing loss …
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CLINICAL_TRIALS trial_result · 2021-05-13Clinical Trial Update: Maribavir for Prevention of CMV After Stem Cell Transplants [Phase 2]
Phase 2 clinical trial update for maribavir in preventing CMV after stem cell transplant has completed.
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CLINICAL_TRIALS trial_result · 2021-02-02Clinical Trial Update: Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin. [Phase 3]
Phase 3 randomized trial evaluating valganciclovir prophylaxis in CMV-seropositive kidney transplant patients to influence thymoglobulin-ind…
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CLINICAL_TRIALS trial_result · 2021-01-05Clinical Trial Update: A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients [Phase 3]
Phase 3 trial update evaluating CMX001 for prevention of CMV infection in CMV-seropositive hematopoietic cell transplantation recipients has…
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CLINICAL_TRIALS trial_result · 2020-12-16Clinical Trial Update: Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation [Phase 2]
Phase 2 trial investigating donor-derived CMVpp65 specific T-cells for treatment of CMV infection or persistent CMV viremia after allogeneic…
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CLINICAL_TRIALS trial_result · 2020-12-11Clinical Trial Update: Pre-engraftment Cytomegalovirus DNAemia
A completed clinical trial update for pre-engraftment CMV DNAemia, with results posted in 2020.
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FDA approval · 2020-11-24FDA Approved: VALCYTE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for VALCYTE (valganciclovir hydrochloride) submitted by H2-Pharma, LLC.
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FDA approval · 2020-06-08FDA Approved: GANCICLOVIR — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for GANCICLOVIR SODIUM from Fresenius Kabi USA, LLC. This action approves a generic version of g…
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FDA approval · 2020-06-08FDA Approved: GANCICLOVIR — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for ganciclovir from Endo USA, Inc., indicating an approved change to the product under the ANDA.
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FDA approval · 2020-03-23FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for PREVYMIS (letermovir) submitted by Merck Sharp & Dohme LLC.
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FDA approval · 2020-03-12FDA Approved: VALGANCICLOVIR — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for valganciclovir hydrochloride (generic product) from Strides Pharma Science Limited.
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FDA approval · 2020-03-12FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for valganciclovir hydrochloride by NorthStar Rx LLC, enabling a generic valganciclovir product.
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FDA approval · 2020-03-12FDA Approved: VALGANCICLOVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic valganciclovir product, authorizing Camber Pharmaceuticals to market valganciclovir fo…
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FDA approval · 2020-01-31FDA Approved: VALGANCICLOVIR HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
FDA approved the original application for valganciclovir hydrochloride (generic valganciclovir) by Somerset Therapeutics, LLC.
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FDA approval · 2019-12-26FDA Approved: VALGANCICLOVIR — Original Application (Ajanta Pharma USA Inc.)
FDA approved the original ANDA for valganciclovir from Ajanta Pharma USA Inc., establishing a generic antiviral product. It is indicated for…