Pharmaceutical Insights
Navigate pharmaceutical trends with our insights on targets, institutional pipelines, clinical advances, and new drugs.
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Recent blog posts
MT-303: Myeloid Therapeutics Launches Phase 1 HCC Trial with RNA CAR Targeting GPC3
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MT-303: Myeloid Therapeutics Launches Phase 1 HCC Trial with RNA CAR Targeting GPC3
6 August 2024
Myeloid Therapeutics begins administering MT-303, a new RNA CAR targeting GPC3, in a Phase 1 trial for late-stage hepatocellular carcinoma (HCC).
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Is Lotilaner approved by the FDA?
Drug Insights
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Is Lotilaner approved by the FDA?
6 August 2024
Lotilaner ophthalmic, marketed under the brand name Xdemvy, has been approved by the FDA for the treatment of Demodex blepharitis.
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SanBio's AKUUGO® for Treating Motor Paralysis in Brain Injury Patients: Approval Achieved
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SanBio's AKUUGO® for Treating Motor Paralysis in Brain Injury Patients: Approval Achieved
6 August 2024
SanBio Gains Approval for "AKUUGO® Suspension for Intracranial Use" (INN: Vandefitemcel) to Treat Persistent Motor Paralysis from Traumatic Brain Injuries.
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Is Donislecel approved by the FDA?
Drug Insights
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Is Donislecel approved by the FDA?
5 August 2024
Donislecel, branded as Lantidra, was approved by the FDA on June 28, 2023. It represents a significant development in the treatment of type 1 diabetes.
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BioNTech Reports Positive Phase 2 Outcomes for mRNA Therapy BNT111 in Advanced Melanoma Patients
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BioNTech Reports Positive Phase 2 Outcomes for mRNA Therapy BNT111 in Advanced Melanoma Patients
5 August 2024
The combination therapy was well tolerated, and the safety profile of BNT111 with cemiplimab was consistent with previous trials of BNT111 with anti-PD-(L)1-based treatments.
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Is Rozanolixizumab approved by the FDA?
Drug Insights
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Is Rozanolixizumab approved by the FDA?
5 August 2024
Rozanolixizumab, marketed under the brand name Rystiggo, was approved by the FDA on June 26, 2023.
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Tectonic Therapeutic Secures US IND Approval for TX45 Lead Program
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Tectonic Therapeutic Secures US IND Approval for TX45 Lead Program
5 August 2024
Tectonic Therapeutic has announced that the U.S. Food and Drug Administration has approved its Investigational New Drug application for TX45.
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Is Ritlecitinib approved by the FDA?
Drug Insights
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Is Ritlecitinib approved by the FDA?
5 August 2024
Ritlecitinib, marketed under the brand name Litfulo, received FDA approval on June 23, 2023, specifically for the treatment of severe alopecia areata.
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Pamrevlumab Trial Results in Advanced Pancreatic Cancer: FibroGen's Update
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Pamrevlumab Trial Results in Advanced Pancreatic Cancer: FibroGen's Update
5 August 2024
FibroGen Releases Main Outcomes from Two Advanced Pamrevlumab Pancreatic Cancer Trials and Shares Corporate News.
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Is Delandistrogene moxeparvovec approved by the FDA?
Drug Insights
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Is Delandistrogene moxeparvovec approved by the FDA?
5 August 2024
Delandistrogene moxeparvovec, known by the brand name Elevidys, received FDA approval for the treatment of Duchenne muscular dystrophy in children on June 22, 2023.
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FDA Clears IND for Umoja's UB-VV111: A CD19 CAR T-Cell Therapy for Blood Cancers
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FDA Clears IND for Umoja's UB-VV111: A CD19 CAR T-Cell Therapy for Blood Cancers
5 August 2024
Umoja Biopharma Receives FDA Approval for IND Application of UB-VV111, a CD19 Targeted CAR T for Blood Cancers.
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Is Vyvgart Hytrulo approved by the FDA?
Drug Insights
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Is Vyvgart Hytrulo approved by the FDA?
5 August 2024
Vyvgart Hytrulo received FDA approval on June 20, 2023. It is approved for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
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