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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
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis
2015-07-23 21:20:21| Biotech - Topix.net
Amgen today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy.
Tags: application
drug
submission
announces
Submission of Supplemental Evidence in an IPR May Be Submitted After...
2015-07-09 08:07:12| Electronics - Topix.net
Submission of Supplemental Evidence in an IPR May Be Submitted After the Due Date - International Business Machines Corp. v. Intellectual Ventures I LLC Addressing the circumstances for submitting supplemental evidence in an inter partes review , the Patent Trial and Appeal Board allowed the petitioner to submit a responsive declaration after the due date for such submissions where the declaration was relevant, the evidence could not be obtained without a subpoena and the patent owner was not prejudiced.
Tags: may
evidence
submitted
submission
Submission of Supplemental Evidence in an IPR May Be Submitted After...
2015-07-09 03:24:46| Semiconductors - Topix.net
Submission of Supplemental Evidence in an IPR May Be Submitted After the Due Date - International Business Machines Corp. v. Intellectual Ventures I LLC Addressing the circumstances for submitting supplemental evidence in an inter partes review , the Patent Trial and Appeal Board allowed the petitioner to submit a responsive declaration after the due date for such submissions where the declaration was relevant, the evidence could not be obtained without a subpoena and the patent owner was not prejudiced.
Tags: may
evidence
submitted
submission
Sarepta Therapeutics Completes NDA Submission To FDA For Eteplirsen For The Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping
2015-07-01 08:07:56| drugdiscoveryonline Home Page
Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, recently announced the completion of the rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for eteplirsen on June 26, 2015
Tags: to
treatment
submission
fda
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