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FDA Accepts Bristol-Myers Combo Application biospace
March 28, 2018
The U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for a type of colorectal cancer.
FDA expands approval of Adcetris for Stage III or IV classical Hodgkin lymphoma europeanpharmaceuticalreview
March 27, 2018
The FDA has approved Adcetris to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy…
FDA approves inclusion of data from safety outcomes trial in the Tresiba® label biospace
March 27, 2018
The following data from DEVOTE in patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) is now included in the label:
Bioness Receives FDA Clearance for myBioness™ iOS app for mobile control of the L300 Go™ System biospace
March 27, 2018
Bioness Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from FDA for the myBionessTM mobile app for use with the L300 Go™ System.
FDA 510(k) Clears ORTHO CONNECT™ Middleware Solution from Ortho Clinical Diagnostics biospace
March 27, 2018
Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, today announced that its ORTHO CONNECT V2.0 middleware solution received 510(k) clearance by FDA.
Amazon hires former FDA data guru to secret health project pharmaphorum
March 26, 2018
Amazon has hired the FDA’s former chief health informatics officer to join its secret health technology business, sparking speculation that the firm could be building a product based around electronic medical records.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities biospace
March 26, 2018
Today, we're taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act
Human Xtensions Receives FDA Clearance for Its HandX, the First in a Line of Smart Digital Handtop Solutions biospace
March 23, 2018
Human Xtensions announces today that they received FDA 510 (k) clearance for HandX(TM).
Respiratory Motion, Inc. is excited to announce FDA clearance for use of the ExSpiron™ 1Xi Minute Ventilation Monitor in Pediatric Patients biospace
March 23, 2018
Respiratory Motion, Inc. reported today that the FDA received approval for its latest version of the ExSpiron Minute Ventilation (MV) monitoring system on Friday, March 16th
Orthofix Receives FDA 510(k) Clearance of G-Beam Fusion Beaming System biospace
March 23, 2018
Orthofix International NV,announced FDA 510(k)clearance for its new internal fixation system, the G-Beam™ Fusion Beaming System.

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