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About 800 results for "pdufa"

FDA extends PDUFA date for review of cobimetinib NDA; Exelixis...

Exelixis (EXEL -7.7%) slumps on average volume in response to the FDA's decision to extend its action date for its review of Genentech's (OTCQX:RHHBY) New Drug Application (NDA) for cobimetinib to November 11 from August 11. The agency feels that ... Seeking Alpha, 5 days ago
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10 images for pdufa

European Pharmaceutical Review, 3 days ago
Pharmaceutical Business Review, 3 days ago
Nasdaq, 2 weeks ago
GlobeNewswire, 2 months ago
Canadian Business Journal, 2 months ago
I Stock Analyst, 2 months ago
Nasdaq, 2 months ago
ClinicSpace, 4 months ago
Pharmaceutical Business Review, 5 months ago
GlobeNewswire, 6 months ago

10 images for pdufa

xeljanz
European Pharmaceutical Review, 3 days ago

BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dys...

FDA Grants Priority Review Status FDA PDUFA Date is December 27, 2015 SAN RAFAEL, Calif., June 29, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the U.S. Food and Drug Administration (FDA) has accepted for ...
 CNN Money1 week ago BioMarin (BMRN) Announces FDA Accepts Drisapersen NDA For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 6/29/2015  ClinicSpace1 week ago BioMarin and Sarepta move ahead with Duchenne candidates  Seeking Alpha1 week ago BIOMARIN PHARMACEUTICAL : Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping  4 Traders6 days ago
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YourEncore eBook and Infographic Highlight 10 Trends Shaping the Pharmaceutical Industry

INDIANAPOLIS, IN -- (Marketwired) -- 06/11/15 -- The PDUFA VI renewal cycle (and other regulatory policies), rising development and prescriptions costs, and potential supply chain vulnerabilities are a few of the trends impacting the pharmaceutical ...
 Town Hall3 weeks ago YOURENCORE : eBook and Infographic Highlight 10 Trends Shaping the Pharmaceutical Industry  4 Traders3 weeks ago
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Merrimack Pharmaceuticals Inc ( MACK )

U.S. FDA Grants Priority Review for MM-398 New Drug Application PDUFA date set for October 24, 2015 Merrimack seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic pancreatic cancer who have been previously ...
 Stock Junction1 week ago U.S. FDA Grants Priority Review for MM-398 New Drug Application  PharmiWeb1 week ago Merrimack seeks US FDA approval for MM-398 to treat patients with pancreatic cancer  PharmaBiz1 week ago Merrimack Release: U.S. FDA Grants Priority Review For MM-398 New Drug Application  BioSpace1 week ago
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European Pharmaceutical Review

Pfizer Announces FDA Acceptance for Review of New Drug Application for A Once-Daily Formulation of XELJANZ® (tofacitinib citrate) Modified Release Tablets

Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) accepted for review Pfizer's new drug application (NDA) for XELJANZ® (tofacitinib citrate) 11 mg once daily modified release tablets for the treatment of moderate ...
 FiercePharmaMarketing11 hours ago FSA accepts for review NDA for a once daily formulation of Xeljanz modified release tablets  European Pharmaceutical Review3 days ago Pfizer's NDA for once-daily XELJANZ modified release tablets to be reviewed by the US FDA for rheumatoid arthritis  Bloomberg3 days ago FDA accepts to review Pfizer's NDA for rheumatoid arthritis drug Xeljanz  Pharmaceutical Business Review3 days ago
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Tofacitinib (Xeljanz) Modified-Release Tablets Accepted for FDA Review

The FDA has accepted for review a new drug application (NDA) for tofacitinib citrate, (Xeljanz, Pfizer) 11-mg once-daily modified-release tablets for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who have shown an ...
 P&T Community7 hours ago
SPi World News

Collegium Added to Russell 2000(R), 3000(R) and Global Indexes

(GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. ( Nasdaq:COLL ) announced that it has been added to the Russell 2000®, Russell 3000®, and Russell Global Indexes as part of Russell Investments' annual reconstitution that took place on June 26, ...
 Crawford Financial Planning6 hours ago Collegium Appoints John Weet VP  Citybizlist5 days ago Collegium Expands Leadership Team With Vice President of Regulatory Affairs and Quality Assurance  BioSpace5 days ago COLLEGIUM PHARMACEUTICAL : Expands Leadership Team With Vice President of Regulatory Affairs and Quality Assurance  4 Traders4 days ago
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Motley Fool

Exelixis to Investors: "Wait for It... No, Seriously, Wait for It!"

Source: Food and Drug Administration via Facebook. Small-cap biopharmaceutical company Exelixis ( NASDAQ:EXEL ) sent a simple message to investors this past week: "Wait for it... No, seriously, wait for it." Exelixis' holding pattern The ...
 Motley Fool1 day ago Exelixis (EXEL) To Investors: "Wait For It... No, Seriously, Wait For It!" 7/6/2015  ClinicSpace12 hours ago
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Go on, take the money and run, as usual

Why would an agency charged with promoting the public health need to be told to consider patients perspectives? Further, why would the Food and Drug Administration need be given two years to come up with a structured risk benefit framework for the ...
 The Hill13 hours ago
Motley Fool

DURECT Announces Plans for a New POSIDUR? SABER-Bupivacaine Clinical Trial

By a News Reporter-Staff News Editor at Clinical Trials Week DURECT Corporation (Nasdaq: DRRX) announced that, based on feedback from the FDA, it plans to conduct a new POSIDUR(?) (SABER()-Bupivacaine) Phase 3 clinical trial consisting of ...
 Pharmacy Choice15 hours ago GILEAD SCIENCES : Submits New Drug Application to U.S. FDA for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide...  4 Traders19 hours ago Gilead Submits New Drug Application to U.S. FDA for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide... [Health & Beauty Close - Up]  Pharmacy Choice15 hours ago Goldman Comments On Vertex After FDA Approval; Arrowhead Initiates Dosing of ARC-AAT in Patients  BioMedReports3 days ago
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