The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
The U.S. Food and Drug Administration (FDA) permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD).
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Sartorius Stedim Biotech is introducing its new generation of ambr® 15 cell culture automated microbioreactor system.
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United Therapeutics and DEKA announced receipt of 510(k) clearance by the FDA for the Unity Subcutaneous Delivery System for Remodulin Injection.
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Haemonetics announced it received 510(k) clearance from the FDA to expand the medical indication of its TEG® 6s Hemostasis Analyzer System for use in ...
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Stryker announced the Premarket Approval (PMA) of the Neuroform Atlas Stent System by the FDA.
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Roche announced FDA 510(k) clearance for the cobas® TV/MG test for use on the cobas® 6800/8800 Systems for the detection of TV and/or MG DNA.
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Abbott announced FDA approval for its new blood and plasma screening Alinity™ s System.
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CVS Health announced the initiation of a clinical trial designed to evaluate the safety and efficacy of the HemoCare™ Hemodialysis System for ...
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Thermo Scientific General Purpose Pro Centrifuge Series has been developed to deliver a safe and regulatory-compliant benchtop separation solution to ...
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Monday, September 16, 2019
Gala Therapeutics announced the FDA granted Breakthrough Device Designation for the RheOx Bronchial Rheoplasty system.
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Tuesday, September 17, 2019
Sanofi SA, Abbott Laboratories
Sanofi and Abbott are partnering to integrate glucose sensing and insulin delivery technologies that would help to further simplify how people with ...
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Tuesday, October 08, 2019
Aethlon announced the FDA has approved its IDE application to initiate an EFS of Hemopurifier® in patients with head and neck cancer in combination ...
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Wednesday, October 09, 2019
Beckman Coulter announced the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the ...
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Wednesday, October 09, 2019
Intarcia announced the FDA has accepted the company's resubmission of its NDA for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes ...
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Thursday, October 17, 2019
Effective immediately, all new Opt-Diss 410 Fiber Optic Dissolution Systems will ship with Windows 10 compatibility unless otherwise noted.
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