BioSpace News Archive

Policy

Orcas Naturals, Inc. and Unique Encapsulation Technology, LLC Receive UL Inspection and Conformance Certifications

GMPs are guidelines that provide a system of processes, procedures, and documentation to assure a product has the identity, strength, composition, quality, and purity that appear on the product label.

September 13, 2018
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2 min read
FDA

FDA to Review EYLEA (aflibercept) Injection for the Treatment of Diabetic Retinopathy

The target action date for the FDA decision is May 13, 2019.

September 13, 2018
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10 min read
BioCapital

India Globalization Capital Raises $1 Million in Direct Equity Investment to Support Hyalolex Commercialization

The net proceeds from the offering are for marketing and working capital associated with the commercialization of Hyalolextm

September 13, 2018
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2 min read
Business

TherapeuticsMD Announces Commercial Availability of Imvexxy™ 4 mcg

Imvexxy 4 mcg dose now commercially available in the United States

September 13, 2018
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10 min read
FDA

Miransertib (ARQ 092) Granted Fast Track Designation for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS)

The FDA’s Fast Track program aims to expedite the development and review of drugs which treat serious or life-threatening conditions and have demonstrated the potential to address unmet clinical needs.

September 13, 2018
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7 min read
Deals

AngioDynamics to Acquire RadiaDyne and its Revolutionary OARtrac® Radiation Dose Monitoring Platform to Further Expand Oncology Portfolio

This transaction expands AngioDynamics’ growing Oncology business

September 13, 2018
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5 min read
FDA

Acorda Announces FDA Extends INBRIJA NDA Review Period

New PDUFA Date of January 5, 2019

September 13, 2018
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5 min read
Business

MPM Capital Expands its Team of Executive Partners and Entrepreneurs with the Appointments of Biotech Leaders Detlev Biniszkiewicz and Scott Chappel

Dr. Biniszkiewicz and Dr. Chappel bring decades of biotech experience and oncology and immuno-oncology research expertise to their respective roles.

September 13, 2018
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5 min read
Pharm Country

World Sepsis Day 2018: CytoSorbents Sponsors the Sepsis Heroes Gala and the Roger Bone Award for Excellence in Sepsis Research

CytoSorbents Corporation commemorates World Sepsis Day 2018 today as a sponsor of the Sepsis Heroes Gala and the Roger Bone Award for Excellence in Sepsis Research.

September 13, 2018
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8 min read
XACT Robotics Receives CE Mark for Its Robotics Navigation System for Percutaneous Procedures

Company closes $5 million in round C investment

September 13, 2018
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4 min read