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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

July 18, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
SCG Cell Therapy SCG101 Hepatitis B virus-related liver cancer IND approved by the FDA for phase 1/2 trials
Annovis Bio Buntanetap Early Parkinson’s disease Study May Proceed letter issued by the FDA for phase 3 trial
Nyxoah Genio system Moderate-to-severe obstructive sleep apnea and complete concentric collapse of the soft palate IDE approved by the FDA
Dyne Therapeutics DYNE-101 Myotonic dystrophy type 1 Phase 1/2 trial approved by New Zealand’s regulatory authority
Rznomics RZ001 Liver cancer IND approved by South Korea’s regulatory authority for phase 1/2a trial
Trials Initiated
Biomica BMC128 plus Opdivo Non-small cell lung cancer, melanoma or renal cell carcinoma Initiation of phase 1 trial
Bio-Thera Solutions BAT8006 Advanced solid tumors Initiation of phase 1 trial
Endevica Bio TCMCB07 Cachexia Initiation of phase 1 trial
Moderna Therapeutics mRNA-1215 Nipah virus vaccine Nipah virus Initiation of phase 1 trial
Propanc Biopharma PRP (trypsinogen and chymotrypsinogen) Advanced cancer Initiation of phase 1 trial
Pulmatrix PUR3100 Acute migraine Initiation of phase 1 trial
Verve Therapeutics VERVE-101 Heterozygous familial hypercholesterolemia Initiation of phase 1 trial
Clinilabs Drug Development CYB003 Major depressive disorder Initiation of phase 1/2a trial
SunHo BioPharmaceutical IAP0971 Locally advanced or metastatic malignant tumors Initiation of phase 1/2 trial
SunHo BioPharmaceutical IAE0972 Locally advanced or metastatic malignant tumors Initiation of phase 1/2 trial
Edgewise Therapeutics EDG-5506 Becker muscular dystrophy Initiation of phase 2 trial
Tetra Therapeutics BPN14770 (zatolmilast) Fragile X syndrome Initiation of phase 2b/3 trial
Overland ADCT BioPharma Zynlonta plus rituximab Diffuse large B-cell lymphoma Initiation of phase 3 trial in China
Biohaven Pharmaceuticals Taldefgrobep alfa Spinal muscle atrophy Initiation of phase 3 trial
Radius Health RAD011 Prader-Willi syndrome Initiation of phase 2/3 trial
Approvals
Horizon Therapeutics Krystexxa (pegloticase) injection co-administered with methotrexate Uncontrolled gout Approved by the FDA for expanded indication
Novavax COVID-19 Vaccine COVID-19 Emergency Use Authorization granted by the FDA
Aurora Spine ZIP MIS implants Lumbar spinal stenosis Approved by the FDA for new indication
Renovia Leva Pelvic Health System Chronic fecal incontinence in women Approved by the FDA

 

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