The US FDA has issued draft guidance on the formal meetings between the FDA and sponsors or applicants of PDUFA products.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
Guidance Explains Expectations for Sponsor-FDA Meetings - FDA News, 1 week ago
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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 Alpha, 2 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 ...PipelineReview, 2 weeks ago Spectrum's NDA for multiple myeloma drug receives FDA acceptance for filing Individual.com, 1 week ago Spectrum Pharmaceuticals Reports Robust Clinical Data and Strong 2014 Financial Results MoneyShow.com, 2 weeks ago Spectrum Pharmaceuticals, Inc. (SPPI) Announces FDA's Acceptance Of NDA Filing For Captisol-Enabled (Propylene Glycol-Free) Melphalan 3/9/2015 ClinicSpace, 2 weeks ago
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 Traders, 1 day ago Ignyta Recaps 2014 Full Year Company Highlights and Financial Results [Professional Services Close - Up] Pharmacy Choice, 1 day ago Ignyta Announces 2014 Full Year Company Highlights and Financial Results Industrial Info Financials, 1 week ago Ignyta Posts 2014 Full Year Company Highlights and Financial Results [Health & Beauty Close - Up] Pharmacy Choice, 1 week ago
(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 Network, 2 days ago Marinus Pharmaceuticals (MRNS)' Ganaxolone Receives FDA Orphan Drug Designation In PCDH19 Female Epilepsy 3/25/2015 ClinicSpace, 2 days ago Selten Pharma's SPI-026 programme gets US FDA orphan drug status to treat pulmonary arterial hypertension PharmaBiz, 1 week ago Selten Pharma receives FDA Orphan Drug designation for PAH Center Watch, 1 week ago
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, ...FiercePharmaMarketing, 2 days ago PFIZER : Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials 4 Traders, 1 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. Butterfield, 3 days ago
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 Alpha, 3 days ago Bristol-Myers Squibb: This Is the Fastest Approval Ive Seen Pettinga Financial Advisors, 3 weeks ago
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 Inc, 3 days ago
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