Tag: FDA
Aviragen Therapeutics Reports Fourth Quarter and Fiscal Year 2016 Financial Results

Miramar Labs’ miraSmooth Procedure Featured on The Rachael Ray Show

SANTA CLARA, Calif., Sept. 14, 2016 (GLOBE NEWSWIRE) -- Miramar Labs, Inc., (OTCQB:MRLB), a global aesthetic company, announced today that its miraSmooth™ treatment was featured in the September 6th episode of “The Rachael Ray Show”, an award-winning and nationally syndicated daytime TV show. The theme of the episode, “Can 3 High-Tech Beauty Treatments Improve Your…

Zynerba Pharmaceuticals Reports Inducement Grant to New Chief Financial Officer

DEVON, Pa., Sept. 13, 2016 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the Company’s Board of Directors granted James Fickenscher, the Company’s newly appointed Chief Financial Officer and Vice President, Corporate Development, an option to purchase 150,000…

BioXcel’s BXCL101, Receives Orphan Drug Designation from the U.S. FDA for the Treatment of Patients with Neurofibromatosis Type 2 (NF2)

BRANFORD, Conn., Sept. 13, 2016 (GLOBE NEWSWIRE) -- BioXcel, a privately held biopharmaceutical company based in Connecticut, today announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Type 2 (NF2), an orphan disease with significant unmet medical need.  BXCL101 is the first…
Vascular Solutions Surpasses 150,000 Successfully Reprocessed ClosureFAST® Catheters

NanoString Technologies Appoints Kirk Malloy, Ph.D. to Board of Directors

SEATTLE, Sept. 13, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the appointment of Kirk Malloy, Ph.D. to the company’s Board of Directors, effective September 12, 2016.  The Board now consists of seven members.  Dr. Malloy is a senior healthcare…

AGTC Announces Financial Results and Business Update for the Quarter and Fiscal Year Ended June 30, 2016

GAINESVILLE, Fla., and CAMBRIDGE, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced financial results for the quarter ended June 30, 2016. “Over the past year we’ve continued to make progress…

pSivida Corp. Provides Company Update and Reports Fourth Quarter and FY 2016 Results

WATERTOWN, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today provided a Company update and announced financial results for its fourth quarter and fiscal year ended June 30, 2016. “Fiscal 2016 was a year of substantial progress for pSivida.…

Adamas Announces Two Data Presentations on ADS-5102 for the Treatment of Levodopa-induced Dyskinesia (LID) at the 4th World Parkinson Congress

EMERYVILLE, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced details regarding two poster presentations highlighting data from EASE LID and EASE LID 3, two completed trials from the company's Phase 3 clinical program of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson's disease, to be presented at the…

Advanced (3D/4D) Visualization Systems Market to Reach US$ 3.28 Bn in 2024; Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 – 2024: TMR

Albany – New York, Sept. 12, 2016 (GLOBE NEWSWIRE) -- According to a new market report published by Transparency Market Research “Advanced (3D/4D) Visualization Systems Market (Platform: Ultrasound, MRI, CT, PET, and Others; Application: Cardiology, Oncology, Neurology, and Others; End-user: Hospitals, Diagnostic Labs, and Academics & Research) – Global Industry Analysis, Size, Share, Growth, Trends, and…

CytoDyn Announces $10.0 Million Registered Direct Offering

VANCOUVER, Washington, Sept. 12, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, today announced that it has entered into definitive agreements with healthcare dedicated institutional investors for an offering of 13,333,334 shares of common stock, at a price…

Flexion Therapeutics Announces Two Key Corporate Appointments

BURLINGTON, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it has made two key appointments to its leadership team: Carolyn Beaty Scimemi, Esq., an experienced compliance and legal professional, as Chief Compliance Officer, and Adam Muzikant, Ph.D., a veteran biotechnology deal negotiator and strategist, as Vice President, Business Development.…

Cellectar Biosciences Announces Lead Compound CLR 131 To Be Studied In Head and Neck Cancer in $12M University of Wisconsin SPORE Grant

MADISON, Wis., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq:CLRB) (“the company”), an oncology-focused biotechnology company, today announces that its lead therapeutic compound, CLR 131, currently in a Phase 1 clinical trial for multiple myeloma and preparing for a Phase 2 study in multiple myeloma and other hematologic malignancies, will be evaluated by…

Celsion Corporation Announces Independent NIH Analysis Showing Treatment with ThermoDox® Plus RFA May Significantly Improve Overall Survival of Patients with Primary Liver Cancer

Conclusions Drawn from Results of Celsion’s HEAT Study Prompted NIH Analysis; Prior Subgroup Analysis of HEAT Study by Celsion Demonstrated a Two-Year Overall Survival Benefit Compared to Treatment with RFA Alone Abstract Accepted for Oral Presentation at the 2016 RSNA Annual Meeting LAWRENCEVILLE, N.J., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced that the…

Aptose Submits Formal Response to Clinical Hold for APTO-253

SAN DIEGO and TORONTO, Sept. 12, 2016 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, announced today that it has submitted a formal response to the U.S. Food and Drug Administration (FDA) regarding the previously announced clinical hold of…

Inovio’s Zika Vaccine Selected As 2016 Technology Breakthrough

PLYMOUTH MEETING, Pa., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its Zika vaccine in development has been named a 2016 Technology Breakthrough by the editors of Popular Mechanics magazine, the leading technology voice in the U.S. with millions of readers. Inovio has advanced its DNA-based Zika vaccine into two…

TESARO Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission

WALTHAM, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a…

Amarin’s REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee

BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 12, 2016 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient…

Adamas Announces New Employment Inducement Grant

EMERYVILLE, Calif., Sept. 09, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that its new Vice President of Corporate Communications and Investor Relations, Martin Forrest, received a grant of an option to purchase 31,875 shares of the company's common stock, at a per share exercise price of $16.13, the closing trading price on…

Review of Xtampza® ER Published in The Journal of the American Medical Association

CANTON, Mass., Sept. 09, 2016 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced the publication of an independent review of Xtampza® ER in The Journal of the American Medical Association (JAMA).  The review titled, “A New Abuse-Deterrent Opioid–Xtampza ER”, was previously published in The Medical Letter.  JAMA is one of the most widely read…
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