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FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis drugs.com
May 18, 2017
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis.
Abon Received Approval from FDA for Clofarabine Injection americanpharmaceuticalreview
May 18, 2017
Abon Pharmaceuticals announced it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Clofarabine Injection, 20 mg/20 mL, Single-use Vial.
FDA Grants Bayer Priority Review for Investigational Compound Copanlisib americanpharmaceuticalreview
May 18, 2017
Bayer announced the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least
Cytokinetics receives FDA orphan drug status for Ck-2127107 to treat SMA pharmaceutical-technology
May 18, 2017
Biopharmaceutical company Cytokinetics’ CK-2127107has received orphan drug designation from the Office of Orphan Products Development of the US Food and Drug Administration (FDA) for the potential treatment of spinal muscular atrophy (SMA).
Vifor Pharma and Akebia to sell Vadadustat to Fresenius Medical Care pharmaceutical-technology
May 18, 2017
Vifor Pharma Group and Akebia Therapeutics have entered an exclusive license agreement to sell Vadadustat to Fresenius Medical Care dialysis clinics located in the US after securing approval from the US Food and Drug Administration (FDA).
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.

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