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- Read more about Thai FDA deemed suitable PharmaCyte Biotech’s encapsulation facility for pancreatic Cancer Therapy
PharmaCyte Biotech, Inc. reported that the encapsulation facility located in Bangkok, Thailand, that will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy has recently been inspected by the Food and Drug Administration of Thailand (Thai FDA). In its report on that inspection, the Thai FDA stated that, “The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products.”
- Read more about FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva™
Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva™ (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.
- Read more about Hikma ANDA for Generic Advair Diskus accepted for filing by FDA
Hikma Pharmaceuticals PLC (Hikma) confirms that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).
- Read more about USFDA grant orphan Drug Designation to ANAVEX 3-71
Anavex Life Sciences Corp. announced that the U.S. Food and Drug Administration (FDA) has granted that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia.
- Read more about Aurobindo Pharma receives USFDA approval for Polymyxin B for injection
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17
- Read more about Corbus pharma announces addition of phase 2 clinical protocol for resunab treatment to FDA IND
Corbus Pharmaceuticals Holdings Inc. announced that a protocol amendment has been added to one of the Company's existing Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration ("FDA") for a Phase 2 clinical trial of Resunab in systemic lupus erythematosus ("SLE").
- Read more about FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
The U.S. Food and Drug Administration approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition. Defitelio is marketed by Jazz Pharmaceuticals based in Palo Alto, California.
- Read more about FDA allows use of investigational test to screen blood donations for Zika virus
The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. The test is manufactured by Roche Molecular Systems, Inc., based in Branchburg, New Jersey.

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- Read more about NATCO Pharma notified on USFDA inspection
Natco Pharma Limited notified that an inspection was conducted by the United States Food & Drug Administration (USFDA) in two of its manufacturing facilities.
- Read more about U.S. FDA grants orphan drug designation to adaptimmune’s T-cell therapy targeting NY-ESO
Adaptimmune Therapeutics plc announced that the U.S. Food and Drug Administration (FDA)'s Office of Orphan Products Development has granted orphan drug designation for the company’s affinity enhanced T-cell therapy targeting NY-ESO for the treatment of soft tissue sarcoma, a solid tumor cancer.