FDA Archives - BioTuesdays

Developments

Akari’s nomacopan gets FDA orphan drug designation for bullous pemphigoid

Akari Therapeutics (NASDAQ:AKTX) received FDA orphan drug designation for nomacopan for the treatment of bullous pemphigoid (BP). BP is a severe orphan inflammatory skin disease characterized by chronic blistering of...

September 13, 2019

Developments

Akari gets FDA orphan drug designation for nomacopan

Akari Therapeutics (NASDAQ:AKTX) received FDA orphan drug designation for nomacopan for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients. HSCT...

August 30, 2019

Developments

Eiger gets FDA breakthrough therapy designation for HDV drug candidate

Eiger BioPharmaceuticals’ (NASDAQ:EIGR) peginterferon lambda (lambda) received FDA breakthrough therapy designation for the treatment of hepatitis delta virus (HDV) infection. HDV is the most severe form of human viral...

August 21, 2019

Developments

Cerecor gets FDA fast track designation for CERC-802

Cerecor (NASDAQ:CERC) received FDA fast track designation for CERC-802 for the treatment of mannose-phosphate isomerase deficiency, also known as CDG-1b. CDG-1b is a rare genetic disease that impacts carbohydrate...

August 21, 2019

Developments

Akari gets FDA fast track designation for nomacopan

Akari Therapeutics (NASDAQ:AKTX) received FDA fast track designation for nomacopan for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients. HSCT-TMA...

August 14, 2019

Developments

FDA clears Mustang Bio IND for CAR T cell therapy

Mustang Bio (NASDAQ:MBIO) reported that the FDA approved its IND application for MB-102 for the treatment of acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk...

August 6, 2019

Developments

Provention Bio gets FDA breakthrough therapy designation for PRV-031

Provention Bio (NASDAQ:PRVB) received breakthrough therapy designation for PRV-031 for the prevention or delay of Type 1 diabetes (T1D) in at-risk individuals. PRV-031, an anti-CD3 monoclonal antibody also known as...

August 6, 2019

Developments

FDA clears Hepion Pharma’s IND for CRV431 for the treatment of NASH

The FDA has authorized Hepion Pharmaceuticals (NASDAQ:HEPA) to proceed with its IND opening study of CRV431 for the treatment of non-alcoholic steatohepatitis (NASH). “Based on the preclinical and clinical studies we’ve...

July 29, 2019

Developments

Aeglea BioTherapeutics gets FDA breakthrough designation for pegzilarginase

Aeglea BioTherapeutics’ (NASDAQ:AGLE) pegzilarginase received FDA breakthrough therapy designation for the treatment of arginase 1 deficiency (ARG1-D). ARG1-D is a rare genetic childhood disease that causes severe...

July 25, 2019

Developments

Matinas gets FDA fast track, QIDP designations for MAT2203

The FDA granted fast track and qualified infectious disease product (QIDP) designations to Matinas BioPharma’s (NYSE AMER:MTNB) MAT2203 for the treatment of cryptococcal meningitis. MAT2203 is a lipid nano-crystal...

July 25, 2019

Tag - FDA

Akari’s nomacopan gets FDA orphan drug designation for bullous pemphigoid

Akari gets FDA orphan drug designation for nomacopan

Eiger gets FDA breakthrough therapy designation for HDV drug candidate

Cerecor gets FDA fast track designation for CERC-802

Akari gets FDA fast track designation for nomacopan

FDA clears Mustang Bio IND for CAR T cell therapy

Provention Bio gets FDA breakthrough therapy designation for PRV-031

FDA clears Hepion Pharma’s IND for CRV431 for the treatment of NASH

Aeglea BioTherapeutics gets FDA breakthrough designation for pegzilarginase

Matinas gets FDA fast track, QIDP designations for MAT2203

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