The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ("FDA") regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").
SENZA-PDN Study is Largest Prospective, Multicenter, Randomized Clinical Trial of Spinal Cord Stimulation Conducted to Date
Treatment leverages proprietary liposomes and first-in-class mechanism-of-action to achieve significant, sustainable pain relief
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.
GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE™) technology platform is pleased to announce the presentation of additional interim data results for the Company's lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS).
Financialnewsmedia.com News Commentary
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM).
Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announced it had official discussions with the FDA on a detailed plan for a phase 1/2 clinical trial to start developing a new treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric disease, using its proprietary drug, OKN-007.
V2ACT Therapeutics™, LLC is a joint venture of Genelux Corporation and TVAX Biomedical, Inc.
BrainEver, a biotechnology company dedicated to the research and development of innovative therapies for the treatment of neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its product BREN-02
The U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs).
Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults and adolescents.
Room-temperature stable formulation aids timely point-of-care administration
The INP104 New Drug Application is Supported by Results from the Phase 3 STOP 301 Study
Phase 1/2 clinical study expected to begin in early 2021; EG-70 is enGene's first clinical-stage product candidate
