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FDA Approves Renflexis drugs.com
April 24, 2017
FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
Aurobindo Pharma gets six observations from US FDA for Hyderabad unit financialexpress
April 21, 2017
US FDA had conducted an inspection at the company’s Unit III, a formulations manufacturing facility at Bachupally, Hyderabad
FDA approves Genentech’s Lucentis for diabetic retinopathy cphi-online
April 21, 2017
First and only medicine FDA-approved to treat all forms of diabetic retinopathy.
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...

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