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News Breaks
October 11, 2012
05:55 EDTVRTX, VRTX, VRTX, ABT, ABT, ABT, ELMD, ELMD, ELMD, DNA, DNA, DNA, GILD, GILD, GILD, HRC, HRC, HRC, HOLX, HOLX, HOLX, NVS, NVS, NVSCystic Fibrosis Foundation to host a conference
26th Annual North American Cystic Fibrosis Conference (NACFC) is being held in Orlando, Florida on October 11-13.
News For VRTX;ABT;ELMD;DNA;GILD;HRC;HOLX;NVS From The Last 14 Days
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October 21, 2014
16:49 EDTVRTXVertex: FDA Advisory Committee recommends approval of KALYDECO
Vertex Pharmaceuticals announced that the U.S. Food and Drug Administrationís Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.
15:35 EDTABTNotable companies reporting before tomorrow's open
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15:25 EDTVRTXPanel backs approval for Vertex CF drug in R117H mutation, Bloomberg says
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15:18 EDTVRTXPanel votes Vertex CF drug safe, works for R117H mutation, Bloomberg reports
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09:37 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL PBR AMZN C TWTR CVX VZ MCD GILD TXN
08:45 EDTGILDGilead Hep C drug barely used in California prisons due to cost, SFGate reports
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07:44 EDTABTAbbott volatility elevated into Q3 and outlook
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07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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07:11 EDTVRTXFDA Pulmonary-Allergy Drugs Advisory Committe to hold a meeting
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
09:36 EDTGILDActive equity options trading on open
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:16 EDTDNAAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:11 EDTHOLXAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
October 17, 2014
16:01 EDTGILDOptions Update; October 17, 2014
iPath S&P 500 VIX Short-Term Futures down 1.75 to 38.58 Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX GILD CLF PBR according to Track Data.
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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10:27 EDTVRTXVertex FDA panel expected to be positive at Piper Jaffray
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10:26 EDTVRTXFDA panel asked to consider benefit of Vertex drug in younger CF patients
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09:38 EDTGILDActive equity options trading on
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October 16, 2014
13:31 EDTGILDGilead announces Harvoni Notice of Compliance from Health Canada
Gilead Sciences announced that Health Canada has issued a Notice of Compliance for Harvoni. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, granted marketing authorization under the tradename Sovaldi in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naive patients without cirrhosis who have baseline HCV viral load below 6M IU/mL. New Drug Submission applications are pending in Australia and New Zealand.
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