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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
CartiHeal raises $ 18.3 Million biospectrumasia
May 10, 2017
The Israeli company CartiHeal is preparing for a human clinical trial of Agili-C, its implant for regenerating damaged cartilage and bone.
FDA approves drug to treat ALS worldpharmanews
May 08, 2017
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease.
Regulus CEO heads to exit as company struggles with FDA hold pharmafile
May 08, 2017
Regulus seemed to be in a good place just last year as its lead drug candidate performed well in a Phase ...
Sangamo Therapeutics Announces Special Regulatory Designations from the FDA americanpharmaceuticalreview
May 05, 2017
Sangamo Therapeutics announced it has received special regulatory designations for three of the company’s clinical programs from the U.S. Food and Drug Administration (FDA).
FDA approves new combination treatment for acute myeloid leukaemia europeanpharmaceuticalreview
May 05, 2017
The US Food and Drug Administration (FDA) has approved Novartis’ Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy

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