Cytomegalovirus Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-05-23FDA Approved: VALGANCICLOVIR — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for valganciclovir from Dr. Reddy's Laboratories Limited, supporting the continued approval of t…
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CLINICAL_TRIALS trial_result · 2024-05-16Clinical Trial Update: Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant [Phase 2, Phase 3]
Clinical trial update reports termination of a Phase 2/Phase 3 study of posoleucel (ALVR105, Viralym-M) for multi-virus prevention in patien…
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CLINICAL_TRIALS research · 2024-05-06Clinical Trial Update: Viral Specific T-Lymphocytes to Treat Adenovirus or CMV [Phase 1, Phase 2]
Phase 1/2 clinical trial evaluating Viral Specific T-Lymphocytes for Adenovirus infection and Cytomegalovirus infection; the study is curren…
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CLINICAL_TRIALS trial_result · 2024-04-25Clinical Trial Update: A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
A completed clinical trial evaluating Cytomegalovirus infection outcomes among solid organ transplant recipients in Europe and Canada. The s…
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CLINICAL_TRIALS trial_result · 2024-04-01Clinical Trial Update: MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) [Phase 3]
Phase 3 trial MK-8228-042 evaluated letermovir for CMV prophylaxis in adult Japanese kidney transplant recipients; results have been posted.
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FDA approval · 2024-03-22FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for LIVTENCITY (maribavir) submitted by Takeda Pharmaceuticals America, expanding its labeling.
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FDA approval · 2024-02-15FDA Approved: GANCICLOVIR — Supplemental Application (Pharmascience Inc.)
FDA approved Pharmascience Inc.'s supplemental application for ganciclovir sodium, allowing its continued marketing as a generic antiviral.
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CLINICAL_TRIALS trial_result · 2024-01-30Clinical Trial Update: Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030) [Phase 2]
Phase 2 pediatric study of letermovir for cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation; results have b…
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CLINICAL_TRIALS trial_result · 2024-01-03Clinical Trial Update: Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults [Phase 2]
Phase 2 dose-finding trial completed evaluating safety and immunogenicity of the CMV vaccine mRNA-1647 in healthy adults.
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CLINICAL_TRIALS trial_result · 2023-10-26Clinical Trial Update: A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients [Phase 2]
Phase 2 trial evaluating CMV vaccine HB-101 in kidney transplant patients has completed with results posted.
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FDA approval · 2023-08-02FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for PREVYMIS (letermovir) from Merck Sharp & Dohme LLC, expanding regulatory authorization.
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FDA approval · 2023-08-02FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for Prevymis (letermovir) submitted by Merck Sharp & Dohme LLC.
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease [Phase 2]
Phase 2 trial update investigating letermovir prophylaxis for CMV in patients with graft-versus-host disease.
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CLINICAL_TRIALS trial_result · 2023-06-22Clinical Trial Update: Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT [Phase 4]
Phase 4 clinical trial update for letermovir as primary prophylaxis of cytomegalovirus infection after R+HID-HSCT.
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FDA approval · 2023-06-05FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for PREVYMIS (letermovir) submitted by Merck Sharp & Dohme LLC.
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FDA label_change · 2023-06-05FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for PREVYMIS (letermovir) submitted by Merck, resulting in changes to its labeling.
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FDA approval · 2023-04-26FDA Approved: LIVTENCITY — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for LIVTENCITY (maribavir) submitted by Takeda Pharmaceuticals America, Inc., resulting in an update…
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CLINICAL_TRIALS trial_result · 2023-04-14Clinical Trial Update: Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant [Phase 2]
Phase 2 trial evaluating the multi-antigen CMV-MVA Triplex Vaccine to reduce cytomegalovirus complications in CMV-seropositive patients unde…
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CLINICAL_TRIALS trial_result · 2023-04-14Clinical Trial Update: Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) [Phase 3]
Phase 3 trial comparing letermovir to valganciclovir for prevention of CMV disease in kidney transplant recipients has completed with result…
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FDA approval · 2023-04-11FDA Approved: VALGANCICLOVIR — Original Application (Florida Pharmaceutical Products, LLC)
FDA approved the original application for valganciclovir from Florida Pharmaceutical Products, LLC, authorizing the generic drug product for…
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CLINICAL_TRIALS trial_result · 2023-03-03Clinical Trial Update: A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants [Phase 3]
Phase 3 trial comparing maribavir to valganciclovir for cytomegalovirus infections in stem cell transplant recipients has completed with res…
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FDA approval · 2023-01-20FDA Approved: PREVYMIS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for PREVYMIS (letermovir) from Merck Sharp & Dohme LLC, updating the labeling as part of the sup…
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CLINICAL_TRIALS trial_result · 2022-12-21Clinical Trial Update: CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation. [Phase 2]
Phase 2 trial evaluating CMV-specific T cell therapy after allogeneic stem cell transplantation in hematologic malignancies with CMV infecti…
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CLINICAL_TRIALS trial_result · 2022-11-01Clinical Trial Update: Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040) [Phase 3]
Phase 3 extension study assessing extending Letermovir prophylaxis from day 100 to day 200 after hematopoietic stem cell transplantation to …
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FDA approval · 2022-10-04FDA Approved: VALGANCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic valganciclovir hydrochloride under an original ANDA (ANDA 211475), adding a generic option for …