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FDA grants Breakthrough Therapy designation to Novartis CTL019 for DLBCL pharmaceutical-technology
April 20, 2017
Novartis’ investigational chimeric antigen receptor T-cell (CAR-T) therapy, CTL019, has received Breakthrough Therapy ...
Rigel Pharmaceuticals submits NDA to FDA for Fostamatinib to treat chronic ITP pharmaceutical-technology
April 20, 2017
Rigel Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for...
FDA Approves Device to Help Curb Cluster Headaches drugs.com
April 20, 2017
Cluster headaches, though rare, are among the most severe forms of headache a person can face.
AMAG Submits Supplemental New Drug Application to FDA for Makena Auto-Injector for Subcutaneous Use americanpharmaceuticalreview
April 20, 2017
AMAG Pharmaceuticals, Inc. announced it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the Makena subcutaneous auto-injector, a drug-device combination product.
US FDA declines approval of Eli Lilly and Incyte’s baricitinib drug to treat RA pharmaceutical-technology
April 19, 2017
Eli Lilly and partner Incyte have announced that the US Food and Drug Administration (FDA) has declined to approve a ...
Genentech's Tecentriq receives FDA-accelerated approval for advanced bladder cancer treatment pharmaceutical-technology
April 19, 2017
Roche Group member Genentech has received accelerated approval from the US Food and Drug Administration (FDA) for Tecentriq...
FDA warns of dangers of Hyland’s homeopathic teething tablets as recall is issued pharmafile
April 19, 2017
After months of FDA warnings, Hyland has finally issued an official voluntary recall of its homeopathic teething tablets, with the US regulatory...
Rigel submits new drug application to FDA for Fostamatinib in Chronic ITP europeanpharmaceuticalreview
April 19, 2017
Rigel Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP).
Orchid Pharma receives EIR from US FDA for Tamil Nadu plant financialexpress
April 19, 2017
The report was issued based on the successful inspection of the formulation manufacturing facility at Irungattukottai
New Bowel Disorder Treatments Needed, FDA Says drugs.com
April 18, 2017
There's no known cause or cure for irritable bowel syndrome (IBS), which affects more than 15 million Americans, according to the U.S. Food and Drug Administration.

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