FDA Approvals

Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation

FDA and Infant Bacterial Therapeutics agree on the design of Phase III study

For an extended time, IBT has consulted with the US FDA on how the company’s planned Phase III study should be designed. IBT announced the...

FDA approves Celgenes R2 for two types of indolent lymphoma

FDA Approvals

Celgene has announced that the US FDA has approved Revlimid (lenalidomide) in combination with rituximab (R2) for patients with previously treated follicular lymphoma (FL)...

WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections

FDA Approvals

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active...

FDA Approves Daiichi Sankyos TURALIO pexidartinib for the Treatment of Select Patients with TGCT a Rare and Debilitating Tumor

FDA Approvals

Daiichi Sankyo Company, Limited announced that the U.S. FDA approved TURALIO as the first and only treatment for adult patients with symptomatic TGCT associated...

Vesselon Acquires FDA-Approved Lipid Microsphere Drug Imagent For Therapeutic Platform

FDA Approvals

Vesselon (www.vesselon.com) an oncology therapeutics company, announced the acquisition of an FDA-approved drug Imagent. Vesselon will use Imagent to create novel therapeutic complexes in...

Stoke Therapeutics Granted FDA Orphan Drug Designation for STK-001, an Investigational New Treatment for Dravet Syndrome

FDA Approvals

Stoke Therapeutics, Inc , a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression,...

Dynacure Receives Orphan Drug Designation from the US FDA for DYN101 an Antisense Medicine to Treat Rare Disease Centronuclear Myopathies

FDA Approvals

Dynacure, a clinical stage drug development company focused on improving the lives of patients with rare and orphan disorders, announced that the U.S. FDA...

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