Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has completed a pre-clinical study using its proprietary and novel RCC-33 formulation on human biopsies, obtained under a Helsinki Committee approved protocol.
An independent FDA advisory committee today signaled in several votes that it does not believe the clinical study data for Biogen's aducanumab supports the drug's approval for patients with early stage Alzheimer's disease.
Tevogen Bio, today announced that its Investigational New Drug (IND) application to develop a COVID-19 treatment using proprietary antigen specific T cell technology has been submitted to the US Food and Drug Administration (FDA).
Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes.
The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.
The U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps).
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that the FDA provided positive feedback during the company's End of Phase 2 (EOP2) meeting for Oramed's oral insulin (ORMD-0801). Based on the FDA's feedback, Oramed intends to initiate two Phase 3 clinical trials following FDA review of those Phase 3 protocols, and nonclinical documents.
Application Seeks to Extend Use of BOTOX® for Patients 5 to 17 Years Old
NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year
If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
EC5026 is the first soluble epoxide hydrolase inhibitor developed to treat neuropathic pain
U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
Agency Continues to Support Competition in Generic Drugs, Increasing Patient Access to More Affordable Medicines
A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list.
Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.
ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and β-thalassemia
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Second Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate in combination with a validated payload (MMAE) and the antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.