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- Read more about FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.
amenable to exon
- Read more about Five Prime Therapeutics Receives FDA Orphan Drug Designation for FPA008 in PVNS
Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for FPA008 for the treatment of Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.
- Read more about Impax Receives Approval of EMVERM™ (mebendazole) Chewable Tablets, 100 mg
Impax Laboratories, Inc. announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets
- Read more about Gilead submits NDA to FDA for Chronic Hepatitis B drug
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.
- Read more about Volpara Solutions Receives FDA Clearance for Volpara Density Maps
Volpara Solutions, the leading provider of automated breast density assessment and quantitative breast imaging tools, announced that it has received a new 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Volpara Density Maps, a new solution designed to help radiologists address the requirement in the BI-RADS 5th Edition Atlas to provide “an overall assessment of the volume of attenuating tissues in the breast, to help indicate the relative possibility that a lesion could be obscured.”

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- Read more about Pluristem Receives U.S. FDA Clearance to Initiate Clinical Trial of PLX-R18
Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The clinical trial is expected to begin in the first half of 2016.
- Read more about ICMR-NICED to step up research on Hepatitis C, rotavirus infection
The National Institute of Cholera and Enteric Diseases (NICED) here on Friday inked a deal with the Bengal Chamber of Commerce and Industry (BCCI) to undertake cutting-edge research on enteric diseases including hepatitis C, and see through translation of research outputs for community outreach.
- Read more about CASI Pharmaceuticals’ Import Drug Registration Application For MARQIBO® Accepted For Review By CFDA
CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced that China’s Food and Drug Administration (CFDA) has accepted for review its import drug registration application for MARQIBO® (vinCRIStine sulfate LIPOSOME injection).
- Read more about Immunovaccin Get USFDA and Health Canada clearance to initiate phase 1b clinical trial for DPX-Survivac with Epacadostat
Immunovaccine Inc, a clinical stage vaccine and immunotherapy company, announced U.S. Food and Drug Administration (FDA) and Health Canada clearance to initiate a clinical study of DPX-Survivac in combination with low-dose cyclophosphamide and epacadostat. Resulting from a recently announced collaboration between Immunovaccine and Incyte Corporation (“Incyte”), the Phase 1b clinical trial will assess the safety and effectiveness of Immunovaccine’s novel T cell activating therapy, DPX-Survivac, along with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease. Immunovaccine anticipates starting the trial, which Incyte will co-fund under the terms of the agreement between the two companies, by Q2 2016.
- Read more about Aquinox Announces Update on Development Program for AQX-1125 Following MEnanta Pharmaceuticals Announces FDA Grants Priority Review To Viekira Pak® NDAeeting With FDA
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s supplemental New Drug Application (sNDA) and granted priority review for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer RBV with VIEKIRA PAK for 12 weeks.