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Home » Pipeline

Pipeline

June 14, 2021
Company Drug/Device Medical Condition Status
Alessa Therapeutics Biolen system in conjunction with radiation therapy localized prostate cancer IND approved by the FDA
Cullinan Oncology CLN-049 relapsed/refractory acute myeloid leukemia IND approved by the FDA
Dynacure DYN101 myotubular and centronuclear myopathies IND approved by the FDA
Ascletis Pharma ASC42 chronic hepatitis B IND approved by the China National Medical Products Administration (NMPA)
Neurescue Neurescue device cardiac arrest treatment Investigational Device Exemption (IDE) approved by the FDA
OraSure Technologies InteliSwab COVID-19 rapid antigen test Emergency Use Authorization (EUA) granted by the FDA
Hoffman-La Roche REGN-COV2 (casirivimab and imdevimab) mild-to-moderate COVID-19 in adults and children 12 years and older who weigh less than 40 kilograms and are at high risk for progression to severe disease Interim Order authorization granted by Health Canada
Regeneron Pharmaceuticals REGEN-COV (casirivimab and imdevimab) mild-to-moderate COVID-19 in adults and children 12 years and older who weigh less than 40 kilograms and are at high risk for progression to severe disease EUA revised by the FDA for lower dose
Alexion Pharmaceuticals Ultomiris (ravulizumab-cwvz) paroxysmal nocturnal hemoglobinuria in children one month of age and older and adolescents approved by the FDA for expanded patient population
Biogen

Eisai
Aduhelm (aducanumab-avwa) Alzheimer’s disease approved by the FDA
Chimerix Tembexa (brincidofovir) smallpox vaccine approved by the FDA
Liminal BioSciences/Prometic Biotherapeutics Ryplazim (plasminogen, human-tvmh) plasminogen deficiency type 1 (hypoplasminogenia) approved by the FDA
Novo Nordisk Wegovy (semaglutide) injection chronic weight management in adults with obesity or who are overweight with at least one weight-related condition approved by the FDA
Pfizer Prevnar 20 (pneumococcal 20-valent conjugate vaccine) prevention of invasive disease and pneumonia caused by the 20 streptococcus pneumoniae (pneumococcus) serotypes in adults approved by the FDA
Vertex Pharmaceuticals Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) children with cystic fibrosis ages six through 11 who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data approved by the FDA for expanded patient population
Innovent

Eli Lilly
Tyvyt (sintilimab injection) in combination with gemcitabine and platinum chemotherapy first-line therapy for unresectable locally advanced or metastatic squamous nonsmall-cell lung cancer approved by China’s NMPA for new indication
AngioDynamics AlphaVac mechanical thrombectomy system mechanical aspiration thrombectomy device for the nonsurgical removal of thrombi or emboli from the vasculature approved by the FDA
Cardinal Health Lymphoseek (technetium Tc 99m tilmanocept) injection lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma or other types of solid tumors approved by the FDA for new indication
Medtronic SenSight directional lead system deep-brain stimulation therapy approved by the FDA
Neurescue Neurescue device temporary occlusion of large vessels, including patients requiring emergency control of hemorrhage approved by the FDA
MiMedx Group EPIFIX allografts wound healing approved by the Japanese Ministry of Health, Labor and Welfare

 

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