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Kelyniam Global Releases Q3 Financials

CANTON, Conn., Dec. 13, 2019 /PRNewswire/ -- Kelyniam Global (OTC: KLYG), a maker of custom cranial implants, released today financial performance for the third quarter of 2019.

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By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  Kelyniam Global, Inc.

FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

SILVER SPRING, Md., Dec. 13, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  U.S. Food and Drug Administration

Boston Scientific Receives FDA Clearance For World's First Single-Use Duodenoscope, EXALT(TM) Model D

MARLBOROUGH, Mass., Dec. 13, 2019 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT(TM) Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  Boston Scientific Corporation

Statement from Aaron J. Kowalski, Ph.D., President and CEO of JDRF, on the U.S. Food and Drug Administration (FDA) authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system

NEW YORK, Dec. 13, 2019 /PRNewswire/ -- "Regulatory authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system is a huge win for the type 1 diabetes (T1D) community and a critical step forward in making day-to-day life better for people living with the disease.

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By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  JDRF | JDRF T1D Fund

FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

SILVER SPRING, Md., Dec. 13, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI)... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  U.S. Food and Drug Administration

ITF Pharma Announces FDA Approval of Supplemental New Drug Application (sNDA) for TIGLUTIK® (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) with a Percutaneous Endoscopic Gastronomy (PEG) Feeding Tube

BERWYN, Pa., Dec. 13, 2019 /PRNewswire/ -- ITF Pharma, a U.S.-based specialty pharmaceutical company and subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its application to broaden... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  ITF Pharma

Immunicum AB (publ) Announces Resignation of Carlos de Sousa as CEO

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By: GlobenewsWire - 13 Dec 2019
Related companies:  Immunomedics, Inc.

Bavarian Nordic Receives Antitrust Clearance for Acquisition of Rabipur/RabAvert and Encepur from GlaxoSmithKline

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By: GlobenewsWire - 13 Dec 2019
Related companies:  Bavarian Nordic A/S

Financial calendar 2020

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By: GlobenewsWire - 13 Dec 2019

Hansa Biopharma has Agreed With the FDA on a Regulatory Path Forward for Imlifidase in Kidney Transplantation of Highly Sensitized Patients in the U.S.

LUND, Sweden, Dec. 13, 2019 /PRNewswire/ -- Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced the outcome of a November 20th meeting with the U.S. Food and Drug Administration (FDA) to discuss a regulatory path forward for imlifidase... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  Hansa Biopharma AB

Innate Pharma Provides Update on Lacutamab TELLOMAK Trial

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By: GlobenewsWire - 13 Dec 2019
Related companies:  Innate Pharma S.A.

Roche announces positive Phase III study results for Tecentriq plus Cotellic and Zelboraf in people with previously untreated BRAF V600 mutation-positive advanced melanoma

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By: GlobenewsWire - 13 Dec 2019
Related companies:  F. Hoffmann-La Roche AG (Venture Fund) | Hoffmann-La Roche Limited (Roche Canada) | F. Hoffmann-La Roche AG | Hoffmann-La Roche Ltd. (Edmonton)

General Meeting approved the project to transfer Pixium Vision’s shares listing to the Euronext Growth Paris market

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By: GlobenewsWire - 13 Dec 2019
Related companies:  Pixium Vision S.A.

Innate Pharma Provides Update on Lacutamab Tellomak Trial

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By: GlobenewsWire - 13 Dec 2019
Related companies:  Innate Pharma S.A.

PointNurse Reaches Milestone on Path to Digital Health Provider Leadership

NASHVILLE, Tenn., Dec. 12, 2019 /PRNewswire/ -- PointNurse, a digital health care provider community, has announced reaching a critical... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019

Clinical Data from Reprieve Cardiovascular's Successful First-in-Human Therapy for Acute Heart Failure Presented

MILFORD, Mass., Dec. 13, 2019 /PRNewswire/ -- Reprieve Cardiovascular(®), a pioneering medical device company focused... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
Related companies:  Reprieve Cardiovascular, Inc.

Sarepta Therapeutics Announces FDA Approval of VYONDYS 53™ (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53

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By: GlobenewsWire - 13 Dec 2019
Related companies:  Sarepta Therapeutics Inc.

Zurich Malaysia partners with DoctorOnCall to provide Malaysians a convenient way to manage their health

KUALA LUMPUR, Malaysia, Dec. 13, 2019 /PRNewswire/ -- Zurich Life Insurance Malaysia Berhad and Zurich Takaful Malaysia Berhad (Zurich Malaysia) have recently signed an agreement with leading online healthcare provider DoctorOnCall to extend complimentary* digital healthcare services to its new... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019

IRLAB Has Carried Out a Directed Issue of SEK 70 Million and Resolves on a Rights Issue of Approximately SEK 145 Million

STOCKHOLM, Dec. 12, 2019 /PRNewswire/ -- NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, UNITED KINGDOM, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL PURSUANT... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019

AARP Pennsylvania Applauds the U.S. House for Passing the Elijah E. Cummings Lower Drug Costs Now Act

HARRISBURG, Pa., Dec. 12, 2019 /PRNewswire/ -- AARP Pennsylvania State Director Bill Johnston-Walsh released the following statement today, applauding Reps. Boyle, Cartwright, Dean, Doyle, Evans, Fitzpatrick, Houlahan, Lamb, Scanlon, and Wild of the U.S. House of Representatives for voting to... Read more ››

By: PR Newswire Association LLC. - 13 Dec 2019
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