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About 800 results for "pdufa"

US FDA issues draft guidance on formal meetings for applicants...

The US FDA has issued draft guidance on the formal meetings between the FDA and sponsors or applicants of PDUFA products. The industry needs to revert to the global regulator by June end. This guidance provides recommendations to industry on ... PharmaBiz, 1 week ago

3 images for "pdufa"

ClinicSpace, 1 month ago
Pharmaceutical Business Review, 1 month ago
GlobeNewswire, 2 months ago

PDUFA date approaches for Kalydeco label expansion

Are you Bullish or Bearish on ? Bullish Bearish Results for ( ) Bullish Bearish Thanks for sharing your thoughts. Submit & View Results Skip to
 Seeking Alpha1 week ago

Next Week In Biotech: Vertex PDUFA, Organon Ad Comm

Every week, Seeking Alpha aggregates expected biotech events in an effort to alert readers and contributors to upcoming catalysts. Crowdsourcing is key, so please let us know about any events we may have missed. Have a view on something that's ...
 Seeking Alpha2 weeks ago

Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Captisol-Enabled(TM) (Propylene Glycol-Free) Melphalan

Details Category: Small Molecules Published on Monday, 09 March 2015 16:28 Hits: 34 PDUFA decision expected October 23, 2015, 10 months from NDA filing. Approval is being sought for use as a high-dose conditioning treatment prior to stem cell ...
 PipelineReview2 weeks ago Spectrum's NDA for multiple myeloma drug receives FDA acceptance for filing  Individual.com1 week ago Spectrum Pharmaceuticals Reports Robust Clinical Data and Strong 2014 Financial Results  MoneyShow.com2 weeks ago Spectrum Pharmaceuticals, Inc. (SPPI) Announces FDA's Acceptance Of NDA Filing For Captisol-Enabled (Propylene Glycol-Free) Melphalan 3/9/2015  ClinicSpace2 weeks ago
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IGNYTA : Recaps 2014 Full Year Company Highlights and Financial Results

Ignyta reported company highlights and financial results for the full year ended December 31, 2014 . "Since the beginning of 2014, we have made significant progress toward our goal of becoming a leading precision oncology biotechnology company," ...
 4 Traders1 day ago Ignyta Recaps 2014 Full Year Company Highlights and Financial Results [Professional Services Close - Up]  Pharmacy Choice1 day ago Ignyta Announces 2014 Full Year Company Highlights and Financial Results  Industrial Info Financials1 week ago Ignyta Posts 2014 Full Year Company Highlights and Financial Results [Health & Beauty Close - Up]  Pharmacy Choice1 week ago
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Marinus Pharmaceuticals' Ganaxolone Receives FDA Orphan Drug Designation in PCDH19 Female Epilepsy

(GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. ( Nasdaq:MRNS ), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced that the United States Food and Drug Administration (FDA) has ...
 Wall Street Business Network2 days ago Marinus Pharmaceuticals (MRNS)' Ganaxolone Receives FDA Orphan Drug Designation In PCDH19 Female Epilepsy 3/25/2015  ClinicSpace2 days ago Selten Pharma's SPI-026 programme gets US FDA orphan drug status to treat pulmonary arterial hypertension  PharmaBiz1 week ago Selten Pharma receives FDA Orphan Drug designation for PAH  Center Watch1 week ago
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Pfizer Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials

Pfizer Inc. (NYSE:PFE) announced today the presentation of detailed pooled results from two pivotal Phase 3 studies from theOral treatmentPsoriasisTrials (OPT) program at the 73rdAmerican Academy of Dermatology (AAD) Annual Meeting. These results, ...
 FiercePharmaMarketing2 days ago PFIZER : Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials  4 Traders1 week ago
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Butterfield Seeks to Make Expediting Treatments for Rare Pediatric Diseases Permanent through Introduction of Bipartisan Advancing Hope Act

WASHINGTON, DC Congressman G. K. Butterfield (NC-01) today introduced the Advancing Hope Act of 2015 , a bipartisan bill that will make permanent the Rare Disease Priority Review Voucher Program, which was created through the inclusion of the ...
 Congressman G.K. Butterfield3 days ago

Bristol-Myers Squibb's Opdivo Breezes Through FDA; Multiple Catalysts To Come

Mar. 24, 2015 8:52 AM ET | About: Bristol-Myers Squibb Company (BMY) by: Vuru Summary Bristol-Myers Squibb's Opdivo (nivolumab) used for the treatment of patients with metastatic squamous NSCLC (non-small cell lung cancer) with progression on ...
 Seeking Alpha3 days ago Bristol-Myers Squibb: This Is the Fastest Approval Ive Seen  Pettinga Financial Advisors3 weeks ago
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Global Information Inc

Physician Views: Pfizer delivered regulatory promise with Ibrance, can it deliver a strong launch?

While much of the focus at Pfizer continues to be sharpened on M&A activity, recent approval of Ibrance (palbociclib) for the first-line treatment of ER+/HER2- breast cancer may have been overlooked in some quarters. It should not be. Ibrance not ...
 Global Information Inc3 days ago
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