Aslan Pharmaceuticals’ Varlitinib Receives Orphan Drug Designation for Treatment of Cholangiocarcinoma

Aslan Pharmaceuticals, a pharmaceutical company headquartered in Singapore received Orphan Drug Designation from the U.S. FDA for its varlitinib for the treatment of cholangiocarcinoma.  Varlitinib is an orally bioavailable pan-HER inhibitor...

U.S. FDA Granted Orphan Drug Designation to Inecalcitol for Treatment of Acute Myeloid Leukemia

The U.S. FDA granted Orphan Drug Designation (ODD) to inecalcitol for the treatment of acute myeloid leukemia (AML).  Inecalcitol is a vitamin D3 receptor agonist under clinical development by Hybrigenics, a...

Paratek Pharmaceuticals Receives FDA Fast Track Designation for Omadacycline

Paratek Pharmaceuticals, Boston-based biopharmaceutical company, announced that the U.S. FDA has granted omadacycline Fast Track Designation for the development of omadacycline in Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community Acquired...

Loxo Oncology Announces FDA Orphan Drug Designation Granted to LOXO-101 for Treatment of Soft...

The U.S. FDA has granted orphan drug designation to LOXO-101 for the treatment of soft tissue sarcoma.  LOXO-101 is an oral and selective inhibitor of tropomyosin receptor kinase (TRK) and is...

FDA Approved Natpara, the First Biologic to Treat a Rare Disease, Hypoparathyroidism

NPS Pharmaceutical, Inc., headquartered in Bedminster, New Jersey, USA, won FDA approval on January 23, 2015 for Natpara, the first bioengineered replacement therapy cleared for U.S. marketing to treat hypoparathyroidism.  FDA...

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WuXi AppTec Expands Site in the United States for Drug Development...

We are pleased to announce the grand opening of WuXi AppTec's expanded Laboratory Testing Division (LTD) facility in New Jersey. The expansion will double total...