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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, 1 day ago

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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 Net6 days ago Alimera/pSivida Seek FDA Approval for Iluvien - Analyst Blog  Nasdaq5 days ago The Stalled State Of MannKind  Seeking Alpha1 week ago If MannKind Keeps Pulling Back, It's A Buying Opportunity  Seeking Alpha1 week ago

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! Finance4 days ago
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.com6 days ago pSivida Announces September 26, 2014 PDUFA Date for ILUVIENĀ®  Business Wire6 days ago pSivida partner gets new PDUFA date for Iluvien  Australian Life Scientist6 days ago Alimera Sciences Announces Sept 26th PDUFA Date for ILUVIEN  Benzinga.com6 days ago

BioDelivery Sciences reviews its business and updates milestones for 2014

( BDSI ) files its 10-K and provides an update on its key initiatives. BUNAVAIL PDUFA date is June 7, 2014. Positive Phase III top-line results reported for BEMA Buprenorphine. 2013 R&D expense was $53.3M ($41.8M for BEMA). Net loss was $57.4M ...
 Seeking Alpha1 month ago BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its 2013 Annual Report  Reuters1 month ago BioDelivery Sciences Announces Four BUNAVAIL Abstracts to be Presented at the 2014 American Society of Addiction..  ADVFN India1 week ago BioDelivery Sciences Announces First Patient Enrollment in Phase 3 Clinical Study of Clonidine  Benzinga.com2 weeks ago

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, ...
 FierceBiotech3 days ago

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 Pharma1 week ago Inhalable Insulin Wins FDA Advisory Panel Nod  QMED1 week 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 Media1 week 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.com1 week ago


LEIDEN, NETHERLANDS and RALEIGH, NC, February 24, 2014 - Pharming Group NV (NYSE Euronext:PHARM) and Salix Pharmaceuticals, Ltd
 Andhra News1 month ago MannKind : PharmApprove Client MannKind Achieves Positive Votes from Key FDA Advisory Committee  4 Traders2 weeks ago PharmApprove Client MannKind Achieves Positive Votes from Key FDA Advisory Committee  MySanAntonio2 weeks ago
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