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Pipeline
June 21, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Asieris Pharmaceuticals | APL-1202 in combination with BeiGene's tislelizumab | neoadjuvant therapy in patients with muscle-invasive bladder cancer | IND approved by the FDA |
| ImmunityBio | Anktiva in combination with standard chemotherapy and Trodelvy (sacituzumab govitecan-hziy) | advanced triple-negative breast cancer | IND approved by the FDA |
| Oryzon Therapeutics | vafidemstat | borderline personality disorder | IND approved by the FDA for phase 2b trial |
| Xilio Therapeutics | XTX101 | solid tumors | IND approved by the FDA |
| Siranomics | STP705 | skin squamous-cell carcinoma in situ | IND approved by China’s National Medical Product Administration |
| LivaNova | aura6000 System, implantable hypoglossal neurostimulator | moderate-to-severe obstructive sleep apnea in adults | Investigational Device Exemption approved by the FDA |
| Quidel | Sofia Q | rapid antigen test device | Emergency Use Authorization granted by the FDA |
| Blueprint Medicines | Ayvakit (avapritinib) | advanced systemic mastocytosis (SM), including aggressive SM and SM with an associated hematological neoplasmand mast-cell leukemia | approved by the FDA |
| Eton Pharmaceuticals | Rezipres (ephedrine hydrochloride injection) | hypotension occurring in the setting of anesthesia | approved by the FDA |
| Gilead Sciences | Epclusa (sofosbuvir/velpatasvir) | chronic hepatitis C in children as young as three years regardless of HCV genotype or liver disease severity | approved by the FDA for new formulation |
| AVITA Medical | Recell System in combination with meshed autografting | treatment of all sizes of acute full-thickness thermal burn wounds for both pediatrics and adults | approved by the FDA for expanded use |
| Neo Medical Osartis |
Neo Pedicle Screw System in combination with BonOs Inject cement | compromised bone quality in late-stage tumors | approved by the FDA |
| Stratatech | StrataGraft | deep partial-thickness burns | approved by the FDA |
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