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Tag: fda
Osmotica Announces FDA Acceptance Of Filing For Ontinua ER For Alleviation Of Spasticity Resulting From Multiple Sclerosis And Strong Advancement In The Clinical Program For Osmolex ER
2015-09-30 08:56:43| drugdiscoveryonline News Articles
Osmotica Pharmaceutical Corp. (privately held), a global specialty pharmaceutical corporation developing best-in-class therapeutics for the treatment of CNS diseases, announced recently that the New Drug Application (NDA) for OntinuaTM ER has been accepted for filing by the U.S. Food and Drug Administration (FDA)
Intersect ENT Announces FDA Submission To Seek Expanded Indication Of PROPEL Mini Steroid Releasing Implant To Treat Patients With Frontal Sinus Disease
2015-09-30 08:48:02| drugdiscoveryonline News Articles
Intersect ENT, Inc., a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, recently announced that the company has submitted a supplemental premarket approval (PMA-s) submission to the U.S
Tags: mini
expanded
disease
patients
Merck KGaA, Darmstadt, Germany, And Pfizer Announce FDA Orphan Drug Designation For Investigational Immunotherapy Avelumab In Merkel Cell Carcinoma
2015-09-30 08:25:02| drugdiscoveryonline News Articles
Merck KGaA, Darmstadt, Germany, and Pfizer recently announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for the investigational cancer immunotherapy avelumab* for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer
Tags: germany
cell
drug
announce
Califf nominated to be FDA commissioner
2015-09-28 18:13:00| National Hog Farmer
By P. Scott Shearer, Bockorny Group, Washington, D.C. Robert Califf has been nominated by President Obama to serve as the next commissioner of the U.S. Food and Drug Administration. read more
Tags: commissioner
nominated
fda
FDA Finalizes FSMA Rules for Preventive Controls
2015-09-25 21:18:00| Food Processing
At long last, the FDA finalized the first two of seven major rules required by Congress under the Food Safety Modernization Act.
Tags: rules
controls
fda
preventive
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