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About 800 results for "pdufa"

Emmaus Life Sciences Receives Notice of FDA PDUFA Date for Inv...

Emmaus Life Sciences, Inc. announced today that the U.S. Food and Drug Administration has set a PDUFA date of July 7, 2017 for a decision on the Company's New Drug Application for its orally-administered pharmaceutical grade L-glutamine (PGLG) ... Asia Net, 14 hours ago

31 images for pdufa, 2 weeks ago
Medtech Insight, 1 month ago, 1 month ago
BioSpace, 1 month ago
Nasdaq, 1 month ago
Yahoo! Singapore, 1 month ago, 2 months ago
Scrip Intelligence, 2 months ago
European Pharmaceutical Review, 2 months ago
Scrip Intelligence, 2 months ago
Yahoo! Finance

5 BioPharma Catalysts Expected Around Christmas

Biotech stocks are risky propositions that gyrate up and down violently in reaction to catalysts, including PDUFA dates, clinical trials and FDA decisions. After years of investment of time (usually assumed to be roughly 12 years), efforts and money ...
 Benzinga.com1 week ago

BRIEF-Kedrion Biopharma, Kamada- FDA accepts rabies immunoglobulin review

n"Nov 7 Kamada Ltd * Kamada ltd- pdufa goal date of august 29, 2017 * Kedrion biopharma and kamada announce fda acceptance of bla submission for human rabies immunoglobulin as a post-exposure treatment Source text for Eikon: Further company ...
 Reuters UK4 weeks ago BRIEF-Kedrion Biopharma and Kamada announce FDA acceptance of BLA submission  Reuters UK4 weeks ago ARIAD Reports Third Quarter 2016 Financial Results  BioMedReports4 weeks ago Kedrion Biopharma and Kamada Announce FDA Acceptance of BLA Submission for Human Rabies Immunoglobulin as a Post-Exposure Treatment  TradingCharts.com4 weeks ago

Bet On Baricitinib - Buy Incyte Before The January PDUFA Date

In the wake of the pharma decline leading up to the election, the size of the opportunity to bet on clinical outcomes is greatly amplified by beaten down stock prices. Take Incyte ( NASDAQ: INCY ), for example. INCY is trading 26% off its 52 week ...
 Seeking Alpha4 weeks ago

FDA Grants Priority Review To SBLA For Merck''s KEYTRUDA

The FDA granted Priority Review with a PDUFA, or target action, date of March 15, 2017. The sBLA will be reviewed under the FDA's Accelerated Approval program. In April 2016, KEYTRUDA was granted Breakthrough Therapy Designation by the FDA for this ...
 Nasdaq5 days ago Merck's Keytruda gets US FDA Priority Review status for advanced MSI-H cancer  PharmaBiz6 days ago FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Merck's KEYTRUDA (pembrolizumab) in Relapsed or Refractory Classical Hodgkin Lymphoma  Pharmacy Choice4 days ago Formatting failings set to delay FDA ruling on cancer drug  FierceBiotech1 week ago


Because of PDUFA, the United States now leads the world in the introduction of new medicines and the FDA is the global gold standard for regulatory review and approval. PDUFA VI builds upon the successes of previous PDUFA agreements with continued ...
 Innovation.org2 weeks ago

Egalet Notified that FDA Will Not Meet PDUFA Goal Data for ARYMO ER

WAYNE, Pa., Oct. 13, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq:EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, ...
 Nasdaq1 month ago

A Quick Update On Egalet

"The two most powerful warriors are patience and time". - Leo Tolstoy I have received quite a few questions recently around what is happening with Egalet (NASDAQ: EGLT ), a small biopharma stock we have profiled on these pages. I did a deep ...
 Seeking Alpha1 hour ago
Main Street

FDA's Office of New Drugs director to retire

John Jenkins, MD, director of the Office of New Drugs (OND) at FDA, will retire next year, with Janet Woodcock set to run the office in the interim. For the past 15 years, Jenkins has led OND in its tasks of setting U.S. John Jenkins, MD, ...
 Pharmacist.com2 hours ago FDA OND Director Jenkins to Retire  Genetic Engineering News3 hours ago Fast-Tracking Drugs Through the FDA Has Side Effects  Main Street3 weeks ago

Matinas Biopharma Holdings, Inc. (MTNB: OTCQB) | Matinas BioPharma Commences Dosing in Phase 1 Studyof Orally Administered Aminoglycoside Antibiotic MAT2501

OTC Disclosure & News Service - MAT2501 previously received Orphan Drug and Qualified Infectious Disease Product designations for treatment of nontuberculous mycobacterium infections by U.S. FDA Phase 1 data expected in the first half ...
 OTC Markets1 day ago Matinas BioPharma Commences Dosing in Phase 1 Studyof Orally Administered Aminoglycoside Antibiotic MAT2501  SPi World News1 day ago Matinas starts dosing in phase 1 study of orally administered aminoglycoside antibiotic MAT2501  Pharmaceutical Business Review5 hours ago MATINAS BIOPHARMA : Commences Dosing in Phase 1 Study of Orally Administered Aminoglycoside Antibiotic MAT2501  4 Traders23 hours ago
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