Leading BioSciences Announces FDA Fast Track Designation Granted to LB1148 for the Treatment of Postoperative Gastrointestinal Dysfunction Associated with Pediatric Cardiovascular Surgery

Leading BioSciences, Inc. announced that the FDA has granted Fast Track Designation to LB1148 for the treatment of postoperative gastrointestinal dysfunction associated with pediatric heart surgery.
[Leading BioSciences, Inc. (GlobeNewswire, Inc.)]
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EDAP Announces Positive 24 Month Interim Results of French Urology Association (AFU) Sponsored Clinical Study Comparing HIFU to Radical Prostate Surgery

EDAP TMS SA announced positive 24 month interim results from the “HIFI” study comparing outcomes from high intensity focused ultrasound (HIFU) versus radical prostatectomy in a population of prostate cancer patients. This study is sponsored by the AFU and supported by the French Ministry of Health.
[EDAP TMS]
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Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection) as First-Line Therapy in Hepatocellular Carcinoma (HCC)

Innovent Biologics, Inc. announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application for TYVYT® in combination with BYVASDA® as first-line therapy for patients with HCC.
[Innovent Biologics, Inc.]
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First Patient Enrolls in PRECISIONS Study for Treatment of Idiopathic Pulmonary Fibrosis

The Pulmonary Fibrosis Foundation announced enrollment of the first patient in PRECISIONS clinical trial. This is the first clinical trial to apply the principles of precision medicine to the treatment of patients with idiopathic pulmonary fibrosis.
[Pulmonary Fibrosis Foundation]
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RheinCell Therapeutics Achieves Milestone GMP Certification to Manufacture Cord Blood-Derived iPSCs for Safe and Compliant Cell Therapies

RheinCell Therapeutics GmbH announced it has received Good Manufacturing Practice certification and Manufacturing Authorization. This marks a landmark achievement for RheinCell, which is now among a select few iPSCs manufacturers to have received the critical certification.
[Lifescience Newswire]
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HiberCell and Biodesix Initiate Broad Collaboration for Companion Diagnostic Discovery, Development and Commercialization

HiberCell announced an agreement with Biodesix, Inc. to further the development of an enzyme-linked immunosorbent assay as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs.
[HiberCell]
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Kintara Announces Initiation of Patient Recruitment for VAL-083’s Study Arm in the GBM AGILE Trial

Kintara Therapeutics, Inc. announced that patient recruitment has commenced in the Global Coalition for Adaptive Research registrational Phase II/III clinical trial for glioblastoma (GBM).
[Kintara Therapeutics, Inc.]
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NantKwest, ImmunityBio Announce Positive Interim Data on Survival Rates in Metastatic Pancreatic Cancer Trials

NantKwest, Inc. and ImmunityBio, Inc. announced early interim results of its PD-L1 t-haNK protocols showing median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer for which no other FDA-approved treatment exists.
[NantKwest, Inc.]
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BlueRock Therapeutics in Collaboration with Memorial Sloan Kettering Cancer Center Receives IND Clearance for DA01 in Parkinson’s Disease

BlueRock Therapeutics, in collaboration with Memorial Sloan Kettering Cancer Center, announced that the US FDA has cleared their Investigational New Drug application to proceed with a Phase I study in patients with advanced Parkinson’s disease (PD). This is the first trial in the US to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease.
[BlueRock Therapeutics (PR Newswire, Inc.)]
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Cognito Therapeutics Receives FDA Breakthrough Device Designation for Next-Generation Digital Therapeutic in Alzheimer’s Disease

Cognito Therapeutic. Inc. announced its lead product has received Breakthrough Device Designation from the FDA for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease.
[Cognito Therapeutic. Inc. (Business Wire, Inc.)]
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New Treatment for Central Nervous System Tumors Enters Phase I Clinical Trials

OX2 Therapeutics, Inc. announced that they treated their first patient in a Phase I human trial of a new treatment developed to combat recurrent high-grade brain tumors.
[OX2 Therapeutics, Inc. (Business Wire, Inc.)]
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