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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.
FDA Allows NuvOx Pharma to Run a Phase II Clinical Trial in Brain Cancer americanpharmaceuticalreview
April 18, 2017
Nuvox Pharma announces that the FDA has allowed an Investigational New Drug application to initiate a Phase II clinical trial for its oxygen therapeutic, NVX-108, in patients with the hypoxic solid brain tumor, glioblastoma multiforme.
US FDA inspects Alembic Pharma’s Vadodara plant financialexpress
April 18, 2017
At the end of the observation, no Form 483s were issued
PBOA Praises Action On FDA Reauthorization contractpharma
April 18, 2017
Congress releases a Discussion Draft of the FDA Reauthorization Act for GDUFA
FDA Announces Nationwide Voluntary Recall of Hyland’s Teething Tablets americanpharmaceuticalreview
April 17, 2017
FDA has announced a nationwide voluntary recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets from Standard Homeopathic Company.
FDA Determines Erythropoiesis-Stimulating Agents Risk Evaluation and Mitigation Strategy No Longer N americanpharmaceuticalreview
April 17, 2017
In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS), In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS).
U.S. FDA Issues Complete Response Letter for Baricitinib lilly
April 17, 2017
Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA)...
FDA warning slams St Jude's "inadequate response" to device failures pharmafile
April 14, 2017
St Jude Medical has been hit with a warning letter from the FDA over the medical device manufacturer’s failure to address issues with its implantable defibrillators and at-home monitoring equipment.

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