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Tag: submission
PharmaEngine Announces Merrimack Completed MM-398 (PEP02) New Drug Application Submission To U.S. FDA
2015-04-29 03:56:16| drugdiscoveryonline Home Page
PharmaEngine, Inc. recently announced that its licensing partner, Merrimack Pharmaceuticals, Inc. has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection) to the U.S
Tags: us
application
completed
drug
Merck Announces Submission of Supplemental Biologics License Application (sBLA) to U.S. FDA for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer
2015-04-19 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). Language: English Contact: Media:Pamela Eisele, 267-305-3558orClaire Mulhearn, 908-236-1118orInvestor:Joseph Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
application
license
cell
FY 2014-15 Water Bureau Spring Budget Monitoring Process (BMP) Submission
2015-04-03 19:31:54| PortlandOnline
Tags: process
water
spring
budget
PCI Medical Announces 510(k) Submission to FDA for Automated Reprocessors for Endovaginal/Endorectal Probes and TEE Probes
2015-04-02 12:31:11| Industrial Newsroom - All News for Today
PCI Medical announces that it has submitted the GUS ASTRA VR and GUS ASTRA TEE to the U.S. Food and Drug Administration (FDA) for 510(k) clearance, and that the submission is now in substantive review. The GUS ASTRA VR is an automated reprocessor for the high-level disinfection of endovaginal/endorectal...
Tags: medical
submission
tee
automated
CEREC Meets Invisalign: Sirona Expands Orthodontic Product Line to Include Invisalign Digital Impression Submission
2015-03-16 11:31:15| Industrial Newsroom - All News for Today
BENSHEIM, Germany and SALZBURG, Austria As announced at the IDS 2015, CEREC Omnicam and the new CEREC Ortho Software can be used to submit digital impressions for Invisalign clear aligner therapy. "We are delighted to offer CEREC Omnicam customers the ability to submit digital impressions to the Invisalign...
Tags: include
line
product
digital
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