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ZYNEX SUBMITS FDA APPLICATION FOR ITS NEXT GENERATION FLUID AND BLOOD VOLUME MONITOR

Zynex | January 04, 2022

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Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system. "I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM...

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Pharma Tech

FDA GRANTS BREAKTHROUGH DEVICE DESIGNATION TO WAVEGATE CORPORATION'S STIMULUX

Wavegate Corporation | January 14, 2022

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Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a ...

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PDC LINE PHARMA RAISES €20 MILLION IN SERIES B FINANCING ROUND

Business Wire | January 22, 2020

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PDC line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, announces today the completion of its Series B round of financing. The company has raised a total of €20 million ($22.2M). Two and a half years after its last round of fundraising in July 2017, PDC*line Pharma has attracted new investors, securing a further capital increase of €13.9M ($15.5M). In addition, the company will receive €6.1M ($6.8M) in loa...

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Pharmacy Market

HARBOUR BIOMED ANNOUNCES IND APPROVAL FOR NEXT-GEN ANTI-TSLP FULLY HUMAN MONOCLONAL ANTIBODY

Harbour BioMed | February 22, 2022

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Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collabo...

Read More
news image

Pharma Tech

ZYNEX SUBMITS FDA APPLICATION FOR ITS NEXT GENERATION FLUID AND BLOOD VOLUME MONITOR

Zynex | January 04, 2022

Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system. "I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM...

Read More
news image

Pharma Tech

FDA GRANTS BREAKTHROUGH DEVICE DESIGNATION TO WAVEGATE CORPORATION'S STIMULUX

Wavegate Corporation | January 14, 2022

Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a ...

Read More
news image

PDC LINE PHARMA RAISES €20 MILLION IN SERIES B FINANCING ROUND

Business Wire | January 22, 2020

PDC line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, announces today the completion of its Series B round of financing. The company has raised a total of €20 million ($22.2M). Two and a half years after its last round of fundraising in July 2017, PDC*line Pharma has attracted new investors, securing a further capital increase of €13.9M ($15.5M). In addition, the company will receive €6.1M ($6.8M) in loa...

Read More
news image

Pharmacy Market

HARBOUR BIOMED ANNOUNCES IND APPROVAL FOR NEXT-GEN ANTI-TSLP FULLY HUMAN MONOCLONAL ANTIBODY

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collabo...

Read More

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Feature market insights and perspectives from top C-Level executives, elite technology influencers and thought leaders from your company here. This signature initiative has garnered immense support...

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