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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Aprinoia Therapeutics | APNmAb005 | Tau-related diseases | Study May Proceed letter issued by the FDA |
Blue Earth Therapeutics | 177Lu-rhPSMA-10.1 | Metastatic castration-resistant prostate cancer | IND approved by the FDA |
MediLink Therapeutics | YL201 | Multiple tumor types | IND approved by the FDA |
Triastek | T20 | Cardiovascular and clotting disorders | IND approved by the FDA |
Ilias Biologics | ILB-202 | Cardiac surgery-associated acute kidney injury | Approval for a phase 1 trial granted by Australia’s regulatory authority |
Jiangsu Recbio Technology | ReCOV COVID-19 vaccine | COVID-19 | Phase 2/3 trial approved by the United Arab Emirates regulatory authority |
Trials Initiated | |||
Asana Biosciences | ASN004 | 5T4-expressing advanced solid tumors | Initiation of phase 1 trial |
Chinook Therapeutics | CHK-336 | Hyperoxalurias | Initiation of phase 1 trial |
Exelixis | XL114 | Non-Hodgkin’s lymphoma | Initiation of phase 1 trial |
Immune-Onc Therapeutics | IO-202 | Advanced solid tumors | Initiation of phase 1 trial |
Nabriva Therapeutics | Xenleta (lefamulin) | Cystic fibrosis in adults | Initiation of phase 1 trial |
Sonnet BioTherapeutics | SON-1010 | Advanced solid tumors | Initiation of phase 1 trial |
Sciwind Biosciences | XW004 | Metabolic disease | Initiation of phase 1 trial in Australia |
Caladrius Biosciences | CLBS201 | Diabetic kidney disease | Initiation of phase 1b trial |
Daré Bioscience | DARE-HRT1 | Symptoms of menopause | Initiation of phase 1/2 trial |
Imcyse | Imotope IMCY-0141 | Relapsing-remitting multiple sclerosis | Initiation of phase 1/2 trial |
Inozyme Pharma | INZ-701 | ABCC6 deficiency | Initiation of phase 1/2 trial |
Moderna Therapeutics | mRNA-1020 and mRNA-1030 seasonal influenza vaccines | Seasonal influenza | Initiation of phase 1/2 trial |
MaaT Pharma | MaaT013 in combination with immune checkpoint inhibitors | Metastatic melanoma | Initiation of phase 2a trial in France |
Gannex Pharma | ASC42 | Primary biliary cholangitis | Initiation of phase 2 trial |
IO Biotech | IO102-IO103 plus Keytruda | Nonsmall-cell lung cancer, squamous-cell carcinoma of the head and neck, and urothelial bladder cancer | Initiation of phase 2 trial |
Phosplatin Therapeutics | PT-112 | Recurrent thymic epithelial tumors | Initiation of phase 2 trial |
Surface Oncology | SRF388 plus atezolizumab and bevacizumab | Hepatocellular carcinoma | Initiation of phase 2 trial |
Surface Oncology | SRF388 | Nonsmall-cell lung cancer | Initiation of phase 2 trial |
Akston Biosciences | AKS-452 COVID-19 vaccine | COVID-19 | Initiation of phase 2/3 trial in India |
Approvals | |||
Transit Scientific | XO Cross support catheter platform | Coronary and peripheral vasculature procedures | Approved by the FDA for expanded use |
Astellas Seagen |
Padcev (enfortumab vedotin) | Locally advanced or metastatic urothelial cancer | Approved by the European Union |
AffaMed Therapeutics | Dextenza | Ocular inflammation and pain following ophthalmic surgery | Approved in China |
Novavax | Nuvaxovid COVID-19 vaccine | COVID-19 | Conditional marketing authorization in Switzerland |

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14Apr