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Gemtuzumab ozogamicin
go.drugbank.com/drugs/DB00056ApprovedInvestigationalGemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody [FDA Label]. … Marketing approval of gemtuzumab ozogamicin was granted on May 17, 2000 by FDA as a treatment for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered
Teplizumab
go.drugbank.com/drugs/DB06606ApprovedInvestigational[A241480] On November 2022, teplizumab was approved by the FDA as the first drug that can delay the onset of type 1 diabetes. … [L44096] In April 2026, the FDA approved an expanded indication for teplizumab, lowering the eligible age range from 8 years and older down to 1 year and older for patients with Stage 2 T1D.[L56140]
Vericiguat
go.drugbank.com/drugs/DB15456ApprovedInvestigational[L31178] Vericiguat was approved by the FDA in January 2021 - developed by Merck under the brand name Verquvo - for use in certain patients with systolic heart failure. … [L31178] Although not the first sGC stimulator to be granted FDA approval ([riociguat] was approved in 2013 for use in pulmonary hypertension),[L3955] vericiguat is unique amongst its peers in that modifications
Selumetinib
go.drugbank.com/drugs/DB11689ApprovedInvestigationalMost recently, on November 20, 2025, the FDA expanded this indication to include adults [L53881] … [A193533] Following its initial FDA approval on April 10, 2020,[L49991] and Health Canada approval on August 23, 2022,[L49986] the regulatory landscape has evolved.
Oliceridine
go.drugbank.com/drugs/DB14881ApprovedInvestigational[A218041] Oliceridine gained FDA approval on August 7, 2020, and is currently marketed by Trevena Inc as OLINVYK™.[L15516] … [A218026, A218031, A218051, A218056, A218061, A218066, A218071, L15516] Oliceridine was first reported in 2013,[A218026, A218086] but was initially not approved by the FDA due to concerns raised by
Dabrafenib
go.drugbank.com/drugs/DB08912ApprovedInvestigationalDabrafenib mesylate (Tafinlar) is a reversible ATP-competitive kinase inhibitor and targets the MAPK pathway. It was approved on May 29, 2013, for the treatment of melanoma with V600E or V6000K mutation. It was also used for metastatic n...
Stannous fluoride
go.drugbank.com/drugs/DB11092ApprovedInvestigationalIt is an FDA-approved over-the-counter product.
Triflusal
go.drugbank.com/drugs/DB08814ApprovedWithdrawnUriach and Company and even though it is commercialized in different countries it is not approved by the FDA, EMA or HealthCanada.
Dimethicone 410
go.drugbank.com/drugs/DB14005Approved[L1769] It is currently recognized by the FDA as a skin protectant OTC ingredient for human use in a concentration of 1-30%.
Bimekizumab
go.drugbank.com/drugs/DB12917ApprovedInvestigationalBimekizumab was also granted FDA approval on October 18, 2023.[L48551]