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Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Accutar Biotechnology | AC0682 | Estrogen receptor-positive breast cancers | IND approved by the FDA |
| Biomea Fusion | BMF-219 | Relapsed or refractory acute leukemia | IND approved by the FDA |
| T-Cure Biosciences | KK-LC-1 TCR therapy | Multiple solid tumors | IND approved by the FDA |
| AB Science | AB8939 | Relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome | Approval for a phase 1/2 trial granted by Canada’s regulatory authority |
| Ampio Pharmaceuticals | AP-019 | Respiratory distress due to COVID-19 | Approval for a phase 2 trial granted by India’s regulatory authority |
| Arcutis | ARCT-154 | SARS-CoV-2 delta variant | Approval for a phase 2/3a trial granted by Vietnam’s regulatory authority |
| CytoDyn | leronlimab | Hospitalized COVID-19 patients in critical condition | Approval for a phase 3 trial granted by Brazil’s regulatory authority |
| Inovio | INO-4800 | COVID-19 vaccine | Approval for the phase 3 portion of a phase 2/3 trial granted by Mexico’s regulatory authority |
| OpSens | SavvyWire | Transcatheter aortic valve replacement | Approval for a trial approved by Canada’s regulatory authority |
| Trials Initiated | |||
| Odyssey Group International | PRV-002 | Concussion | Initiation of phase 1 trial |
| Monopar Therapeutics | camsirubicin | Advanced soft tissue sarcoma | Initiation of phase 1b trial |
| Daré Bioscience | DARE-VVA1 | Moderate-to-severe vulvar and vaginal atrophy | Initiation of phase 1/2 trial |
| Bayer | Kerendia (finerenone) | Nondiabetic chronic kidney disease | Initiation of phase 3 trial |
| HutchMed | surufatinib plus toripalimab | Advanced neuroendocrine carcinoma | Initiation of phase 3 trial |
| Tarsier Pharma | TRS01 eye drops | Active noninfectious anterior uveitis | Initiation of phase 3 trial |
| Vicore Pharma | C21 | COVID-19 | Initiation of phase 3 trial |
| Zenith Epigenetics Newsoara BioPharma |
ZEN-3694 plus enzalutamide | Metastatic castration-resistant prostate cancer | Initiation of phase 3 trial |
| Approvals | |||
| Junshi Biosciences | etesevimab and bamlanivimab | Postexposure prophylaxis against COVID-19 in certain individuals age 12 years and older | Emergency Use Authorization expanded by the FDA |
| BeiGene | Brukinsa (zanubrutinib) | Adults with relapsed or refractory marginal-zone lymphoma | Approved by the FDA for expanded indication |
| Exelixis | Cabometyx (cabozantinib) | Treatment of patients age 12 years and older with radioactive iodine-refractory differentiated thyroid cancer | Approved by the FDA for expanded indication |
| Incyte | Jakafi (ruxolitinib) | Chronic graft vs. host disease after failure of one or two lines of systemic therapy in patients older than 12 years | Approved by the FDA for new indication |
| Incyte | Opzelura (ruxolitinib) cream | Atopic dermatitis in patients age 12 years and older | Approved by the FDA |
| Mayne Pharma | Lexette (halobetasol propionate) foam, 0.05% | Plaque psoriasis in patients age 12 years and older | Approved by the FDA |
| Pfizer-BioNTech | Pfizer-BioNTech COVID-19 vaccine booster | Prevention of COVID-19 in people older than 65 years, people under 65 with existing comorbidities and front-line healthcare workers | Approved by the FDA for expanded indication |
| Seagen Genmab |
Tivdak (tisotumab vedotin-tftv) | Recurrent or metastatic cervical cancer | Accelerated approval granted by the FDA |
| Abbott Labs | Portico with FlexNav transcatheter aortic valve replacement system | High-risk patients with symptomatic, severe aortic stenosis | Approved by the FDA |
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