Antisense Pharma Receives FDA Orphan Drug Designation for Trabedersen to Treat Malignant Melanoma

Antisense Pharma Receives FDA Orphan Drug Designation for Trabedersen to Treat Malignant Melanoma

Antisense Pharma GmbH announces that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its investigational oncology antisense compound trabedersen to treat malignant melanoma. Previously, trabedersen has received Orphan Drug designation by the European EMA an ... more

Antisense Pharma Internationalizes Management Board

Antisense Pharma announces the appointment of Dr. Philippe Calais as CEO. The native-born Frenchman has more than two decades of international experience in executive positions in biotech and pharmaceutical companies – including Hofmann La-Roche and ICI Pharmaceuticals – and has successfull ... more

Antisense Pharma Completes Round of Financing Worth Approximately 8 Million Euro

Antisense Pharma announced that MIG Funds 2, 3 and 9 as well as GAF have increased their share capital by approximately 8 million euro. In addition, the current Chief Execute Officer (CEO), Dr. Karl-Hermann Schlingensiepen changed from the operative management of Antisense Pharma to a strat ... more

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Epigenomics submits the fourth module to the FDA for Epi proColon

Epigenomics AG announced that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United States Food & Drug Administration (FDA) for its blood-based Epi proColon® test for the detection of colorectal cancer in December 2012 as previously indicated, thereby co ... more

FDA Approves Genzyme’s AUBAGIO (teriflunomide), a Treatment for Relapsing Multiple Sclerosis

Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures ... more

Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years. Tbo-filgrastim is ... more

U. S. Food and Drug Administration (FDA)

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public hea ... more