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... headquarters.   In June 2019, Misonix announced that it had received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Nexus, its new revolutionary ultrasonic surgical platform. The ...
... for 2019. The first catalyst is a key manufacturing approval from the FDA which appears to have been delayed by the recent government shut-down. That anticipated key FDA decision is set to transform ...
... working with him in his new role," he added.      "We have made very significant progress over the last 18 months," said Mr. Harris. "With the FDA approval to commence Cesca's Phase III ...
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 15, 2015.   Vanda Pharmaceuticals Inc., (NASDAQ: VNDA), announced the U.S. FDA has accepted ...
... by the U.S. Food and Drug Administration (FDA), allowing the company "to design a clinical trial of its INTERCEPT platelets system that would make it available for use in regions of the U.S. with outbreaks ...
... and the U.S. by mid-2015. Cerus' investigational device exemption has been approved by the U.S. Food and Drug Administration (FDA), allowing the company "to design a clinical trial of its INTERCEPT ...
7. Wednesday's Biotech Catalyst Trade Watch List
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... into clinical trials.” In 2010, the Federal Drug Administration (FDA) gave Biodel a complete response letter for Linjecta, which was an injectable, fast acting human insulin for patients with Type I ...
... cancer market are being watched closely. to determine the actual revenue potential for Enzalutamide.  Denderon’s (DNDN) PROVENGE, an FDA-approved drug that was poised to be a blockbuster, is generating ...
... beneficial clinical effects, such as "an improvement in breathing and swallowing ability as well as in muscular power." A month later, in February 2011, the U.S. Food and Drug Administration ("FDA") ...
10. Micro-Cap Stock Trade With Key Timing Component
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... ("FDA") granted Orphan Drug designation to NurOwn, the firm's autologous adult stem cell product candidate for the treatment of ALS. Last month, in June 2011, BrainStorm initiated a Phase I/II clinical ...
... a very interesting biologic, would the FDA really ever approve this?' But your money guys, the investors that are in this are saying watch and see. This is a very interestingly produced, manufactured GMP ...
... one of his "all-time favorites." The BioMedReports FDA Calendar shows several milestones for the company, including some key data reveals this year. I invite our readers to become familiar with CEO Bobby ...
... were blindsided last month (specifically on January 17th) by news from the FDA’s advisory panel which performed a review of the efficacy of Prochieve® progesterone gel. The treatment was supposedly ...
14. Critical decision due
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... last month (specifically on January 17th) by news from the FDA’s advisory panel which performed a review of the efficacy of Prochieve® progesterone gel. The treatment was supposedly meant to reduce the ...
...  that the FDA had accepted for filing a supplemental New Drug Application for Relistor Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain. The FDA has ...
... of Minnesota study, is widely considered one of the world’s top smoking cessation experts.  She is one of nine voting members on the FDA’s Tobacco Product Scientific Advisory Committee, known as TPSAC, ...
...  5) Insider buying of KERX is in the $3 range. Central to the investment thesis and to biotechs in general is that AEZS’ drug has an extremely high likelihood of FDA approval, is currently in ...
Shares of Curis, Inc. (NASDAQ:CRIS) rose in early trading on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has accepted and filed for review Genentech’s new drug application ...
On Monday, Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) announced that yet another abbreviated new drug application (ANDA) has been accepted by FDA officials. Shares of the company rose ...
... the release of drugs into the body.  It’s FDA-approved product DepoCyt(e)® is one example. This is a sustained-release liposomal formulation of the drug cytarabine, which is used for the treatment ...
... pending FDA decision due in November.  The drug delivery company which focuses on orally controlled release devices is based in Montreal and led by President and CEO Dr. Horst Zerbe. The firm ...
22. Extreme Trade Candidate
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... Montreal and led by President and CEO Dr. Horst Zerbe. The firm has a pipeline of 14 products under development and the BioMedReports FDA Calendar and Worldwide Catalyst Tracker shows that the company ...
ViroPharma Inc. (Nasdaq:VPHNM) and micro-cap biotech Intellect Neurosciences (OTCBB:ILNS.PK) said Friday that the two companies had agreed to an exclusive $120 million licensing deal related to Intellect's ...
... company said its agreement with the FDA allows it to seek approval for Qnexa as a treatment for patients that include obese men and women of "non-child bearing potential." Arena (NASDAQ:ARNA), Orexigen ...
... dermatologists and surgeons are starting to use a patient's own (autologus) Adipose (Fat) Stem Cells using Intellicell's process within FDA 361 guidelines. These guidelines make the use of these ...
Over the last 5 weeks, shares of Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX-V:NTB.V) have been dealing with three "non-fundamental/artificial" sources of downward pressure, one ...
... estimated to be extremely common, being the most common in men under 40. This drug has moved further than the others and could hit the market next year. While the FDA has not classified premature ejaculation ...
... been approved by Roswell Park’s Scientific Review Committee and reviewed by the Oncology Division of the FDA (the Food and Drug Administration). CBLI had a chance to review FDA’s comments on this protocol ...
... melphalan program has been granted Orphan Drug status by the FDA as a conditioning treatment for use in autologous transplant for patients with multiple myeloma. This new IV formulation of melphalan ...
... on its progress regarding focus growth initiatives. We believe the most significant update comes in the form of the recently announced FDA approval to start the EXCITE in-stent restenosis (ISR) trial. ...
31. Long-term winner holding strong
(Home Page/Home Page)
... Acuform technology to modify existing drugs already approved by the FDA. Their Acuform technology allows for targeted, controlled delivery with meaningful benefits, including greater treatment efficacy, ...
... combined company will have an extensive pipeline of abbreviated new drug applications (ANDAs) with 46 ANDAs under active FDA review in multiple therapeutic areas, including pain, urology, CNS, as well ...
... Inc. (NYSE: FRX) announced after the market close that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted 21 – 0 in favor of approval of ceftaroline fosamil for ...
... program to resolve the sole remaining chemistry, manufacturing & control (CMC) issue necessary to potentially gain FDA marketing approval for Surfaxin(R) (lucinactant) for the prevention of Respiratory ...
The BioMedReports.com FDA Calendar database includes over 350 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and ...
...  "Why wasn't VRMLQ on your FDA Calendar as one of the companies to invest in?" "How could you guys miss this?" We had omitted the company because we would never knowingly advise anyone to invest in ...
37. A New Drug Delivery, Diabetes Monitoring Extreme Trade
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Below is a new entry to the BioMedReports.com FDA Calendar database that represents an extreme trade on an innovative system for blood glucose monitoring for diabetics, in addition to a drug delivery system. ...
...  Peregrine will begin reverse stock split on Monday FDA Calendar Extreme Trades: 85 Single Digit Stocks Preliminary data at the end of the six planned treatment cycles in the Phase II ...
... MucoAdhesive) Film Technology, while seeking FDA approval through the 505(b)(2) pathway, which represents a lower risk / cost and quicker route to commercialization as compared to the process of developing ...
... the most recent corporate presentation for IntelGenx (IGXT.OB) (IGX.V), including the following update below on its pending FDA decision for a novel, once-daily 450 mg formulation of the widely used anti-depressant ...
... (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR ...
The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and ...
43. FDA Calendar Extreme Trades: 85 Single Digit Stocks
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The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and ...
... play on the FDA Calendar Extreme Trade series which is leveraged to the commercial success / targeted marketing of new medical products, devices, and diagnostics. In addition, the nature of early-stage ...
... LE-DT. The first study will be conducted in hormone refractory metastatic prostate cancer patients and the protocol for this study had been submitted to FDA for review.  The Company expects to enroll 40 ...
...  Products *All information taken from company website orBec® GVHD Treatment Their main product, the only Phase III for the past six months, which also has obtained the illustrious FDA Oprhan ...
Discovery Laboratories, Inc. (Nasdaq:DSCO) has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will ...
48. FDA Calendar Updates: Delcath, Pozen, Advanced Life Sciences
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Below are updates to the BioMedReports.com FDA Calendar, which includes a database of 353 entries as of 8/31/09. The calendar was originally created by Mike Havrilla to track companies with pending new ...
49. DepoMed: A Drug Delivery, Dual Trial Extreme Trade
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Below are updates to the BioMedReports.com FDA Calendar, which includes a database of 349 entries as of 8/28/09. The calendar was originally created by Mike Havrilla to track companies with pending new ...
50. Derma Sciences: A Wound Care Extreme Trade
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Below are updates to the BioMedReports.com FDA Calendar, which includes a database of 347 entries as of 8/28/09. The calendar was originally created by Mike Havrilla to track companies with pending new ...

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