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Tag Archives: fda approval

Can Dynavax Technologies Corp. (NASDAQ: DVAX) Overcome FDA Setback for HEPLISAV?

Shares of Dynavax Technologies Corp. (NASDAQ: DVAX) have been getting pounded on Friday following yesterday’s announcement that their lead product candidate HEPLISAV, an adult hepatitis B vaccine, failed to gain the support of an FDA advisory committee concerning safety issues. … Continue reading

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Is Talon Therapeutics (OTCBB: TLON) Worth the Investment Even with an FDA Approval?

After hitting a high of 1.83 just two days ago shares of Talon Therapeutics (OTCBB: TLON) have come crashing down, sinking as low as 0.81 on Wednesday and the bleeding may just be getting started. While TLON is less than … Continue reading

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Viral Genetics Inc. (PINKSHEETS: VRAL) Trying to Manage Massive Deficit While Promoting Advancements in Biotechnology Pipeline

It was almost a year ago that Viral Genetics Inc. (PINKSHEETS: VRAL) was trading at a 52-week high of 0.0490 but eleven months later the small biotechnology company’s shares were at a 52-week low of 0.0090 with an accumulated deficit … Continue reading

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BioDelivery Sciences International, Inc. (NASDAQ: BDSI) Receives Patent Allowance but FDA Approval for BEMA Buprenorphine Remains Critical

Less than two months ago shares of BioDelivery Sciences International, Inc. (NASDAQ: BDSI) were trading at a 52-week low of 0.77 but the fortunes of the specialty pharmaceutical company that develops novel and proprietary patented drug delivery technologies has changed … Continue reading

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Allezoe Medical Holdings, Inc. (OTCBB: ALZM) Acquires Diagnostic Technology for HPV but FDA Approval Remains a Hurdle Yet to be Cleared

With Allezoe Medical Holdings, Inc. (OTCBB: ALZM) announcing on Tuesday that they had acquired the exclusive license to develop and market patent pending, advanced “see and treat” diagnostic technology for Human papillomavirus (HPV), the world’s leading sexually transmitted infection, trading … Continue reading

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Alexza Pharmaceuticals (NASDAQ: ALXA) Gaining Momentum on FDA Approval Recommendation Regarding ADASUVE

Following news that Alexza Pharmaceuticals (NASDAQ: ALXA) received recommendation for FDA approval from the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) relating to their schizophrenia and bipolar mania treatment ADASUVE shares in the pharmaceutical … Continue reading

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Is Cell Therapeutics, Inc. (NASDAQ: CTIC) Any Closer to FDA Approval for non-Hodgkin’s Lymphoma Drug Pixantrone?

The road to FDA approval for Cell Therapeutics, Inc. (NASDAQ: CTIC) has been one littered with speed bumps and potholes yet the biotechnology company now sits just a few months away from potentially clearing the final hurdle and advancing their … Continue reading

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Allezoe Medical Holdings, Inc. (OTCBB: ALZM) Finding it Hard to Convince Investors about HPV Technology while LifeCradle Technology Remains on Life Support

Investors that are considering taking a position in Allezoe Medical Holdings, Inc. (OTCBB: ALZM) based on their recent announcements detailing their agreement to acquire patent pending technology that would enable healthcare providers to “see and treat” Human Papillomavirus (HPV) and … Continue reading

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Will Questions Concerning Benefit-Risk Slow FDA Approval of Seattle Genetics (NASDAQ: SGEN) Cancer Drug Adcetris?

After 14 long years it looks as if Seattle Genetics (NASDAQ: SGEN) is now less than two months away from receiving its first FDA approval. Having taken a giant step on Tuesday following a relatively benign overview offered by the … Continue reading

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BrainStorm Cell Therapeutics (OTCBB: BCLI) Share Price and Volume Jump on Research Analyst Report Despite Absence of Revenue and Products

Take a company like BrainStorm Cell Therapeutics (OTCBB: BCLI), which has been trading around the 0.25 – 0.30 with minimal volume over the past several months, throw in a “Buy” recommendation from a research analyst that predicts share price to … Continue reading

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