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New FDA Commissioner Gottlieb restructures workforce with product-based focus areas pharmafile
May 17, 2017
Scott Gottlieb has wasted no time since his appointment to the role of FDA Commissioner last week.
Sangamo Receives Fast Track Designation from FDA americanpharmaceuticalreview
May 17, 2017
Sangamo Therapeutics announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to SB-525...
Biohaven's Trigriluzole Receives Fast Track Designation from FDA americanpharmaceuticalreview
May 16, 2017
Biohaven Pharmaceutical Holding Company announced the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for Biohaven's product candidate trigriluzole (BHV-4157) for the potential treatment of Spinocerebellar Ataxia (SC
Synthetic Biologics’ SYN-004 secures FDA breakthrough therapy status pharmaceutical-technology
May 16, 2017
Synthetic Biologics has secured breakthrough therapy designation for SYN-004 (ribaxamase) from the US Food and Drug Administration (FDA) to treat Clostridium difficile infection (CDI).
FDA green-lights Alembic's cholesterol drug pharmafile
May 15, 2017
Alembic Pharmaceuticals has announced that its fenofibric acid delayed-release capsules have been approved by the FDA for reducing high cholesterol and increasing good cholesterol.
Alzheimer’s experts call for changes in FDA drug approval standards europeanpharmaceuticalreview
May 15, 2017
Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, Single Endpoint for New Drug Approvals for Alzheimer’s Disease...
SYN-004 Receives Breakthrough Therapy Designation from FDA americanpharmaceuticalreview
May 12, 2017
Synthetic Biologics announced the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection.
Initial Pre-Emergency Use Authorization Submission Made to U.S. FDA for Use of ReCell in a Mass Casu americanpharmaceuticalreview
May 11, 2017
Avita Medical received notification of the initial FDA review of the Pre-EUA (Emergency Use Authorization) submission to allow the emergency deployment of its ReCell device for a mass casualty event involving burn injuries.
FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma drugs.com
May 10, 2017
The U.S. Food and Drug Administration granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma...
US FDA makes eight observations at Lupin’s Aurangabad unit financialexpress
May 10, 2017
The inspection was completed on April 26, 2017

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