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About 801 results for "pdufa"

Flamel Technologies: Great Buying Opportunity Before Earnings ...

Summary Bloxiverz gaining market share. New PDUFA approval by FDA April 28, 2014. Positive data on Narcolepsy drug. Flamel Technologies ( FLML ): Great Buying Opportunity Before Earnings Inflection The biotech sell-off presents a great ... Seeking Alpha, 5 days ago

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Biotech Stock Roundup: MannKind PDUFA Date Pushed Out, Alkermes Impresses with Data

The biotech selloff continued last week with NASDAQ Biotechnology declining 4.46% and the NYSE ARCA Biotech Index declining 5.01% at the end of the week. Even though some companies came up with positive developments, overall sentiment remained ...
 Yahoo! Finance1 week ago
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Seeking Alpha

Bristol-Myers Squibb Submits NDA to FDA for Fixed-Dose Combo Tablet; pSivida Announces PDUFA Date for ILUVIEN

B (BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on April 14, 2014. Bristol-Myers Squibb Company (NYSE: BMY) announced the submission of a new drug ...
 TMC Net1 week ago Alimera/pSivida Seek FDA Approval for Iluvien - Analyst Blog  Nasdaq1 week ago The Stalled State Of MannKind  Seeking Alpha1 week ago If MannKind Keeps Pulling Back, It's A Buying Opportunity  Seeking Alpha2 weeks ago
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Pharma Letter

Alimera Says FDA Has Set New PDUFA Date For Iluvien - Quick Facts

Alimera Sciences, Inc. (ALIM: Quote), a biopharmaceutical company specializing in prescription ophthalmic pharmaceuticals, Monday said that FDA has acknowledged the resubmission of its new drug application for Iluvien and has established September ...
 RTTNews.com1 week ago pSivida Announces September 26, 2014 PDUFA Date for ILUVIEN®  Business Wire1 week ago pSivida partner gets new PDUFA date for Iluvien  Australian Life Scientist1 week ago Alimera Sciences Announces Sept 26th PDUFA Date for ILUVIEN  Benzinga.com1 week ago
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Keryx June volatility elevated into PDUFA

) has been banned for excessive usage. If you believe this was done in error, please email support@financialcontent.com, and include in your email both your IP address as well as the URL you are trying
 Franklin Credit Management Corporation18 hours ago

FDA Sets 22 April 2014 For Moxduo® Advisory Committee Meeting

SYDNEY "As previously announced, our PDUFA date is 25 May, 2014 The Advisory Committee meeting is open to the public and will be held from 8.00am to 5.00pm Additional information can be found on the FDA's website at: ...
 Benzinga.com1 month ago Eagle Pharmaceuticals receives patent for treatment of heat stroke from USPTO  Individual.com1 day ago NDA for Eagle Pharmaceuticals' Orphan Drug Ryanodex for the Treatment of Malignant Hyperthermia Accepted by FDA, Priority Review Granted  Pharmacy Choice3 weeks ago Eagle's exclusive licensor gets US Patent for heat stroke drug dantrolene  Pharmaceutical Business Review3 weeks ago
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Nasdaq volatility delays IPO, Almirall pulls drug over price, Topotarget to merge as PDUFA nears

Welcome to this week's edition of our EuroBiotech Report , in which we have news of how the rise and fall of U.S. biotech and med tech stocks is shaping decisions in Europe. After seeing the Nasdaq medical device index drop 7% in one week, ...
 FierceBiotech6 days ago
QMED

Physician Views: As MannKind's Afrezza nears approval, what opportunity for an inhaled insulin?

MannKind's confirmation that the FDA has extended the PDUFA date for its inhaled insulin Afrezza to July suggests that the diabetes treatment has a better chance of gaining approval. The most likely alternative scenario, postulated analysts, was ...
 FirstWord Pharma2 weeks ago Inhalable Insulin Wins FDA Advisory Panel Nod  QMED2 weeks ago

Louisiana sends Takeda $9-billion Actos bill

The regulator has put off the inhaled insulin's PDUFA date by three months. Phase-III results prompted the drugmaker to pursue a third-quarter filing. Researchers find public service announcements and physician information don't change ...
 Medical Marketing And Media2 weeks ago

Benzinga's Top #PreMarket Losers

MannKind (NASDAQ: MNKD) fell 10.92% to $6.12 in pre-market trading after the company announced that the FDA extended PDUFA date for AFREZZA by 3 months. Himax Technologies (NASDAQ: HIMX) dipped 2.71% to $11.12 in the pre-market session after ...
 Benzinga.com2 weeks ago
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