FDA nixes Akcea’s volanesorsen despite favorable AdComm | Digital Science
The FDA served up a Complete Response Letter for Akcea Therapeutics’ volanesorsen, rejecting the antisense drug for familial chylomicronemia syndrome (FCS), a…
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iCAD Receives FDA Clearance of PowerLook Density Assessment for Digital…
August 8, 2018 — iCAD announced U.S. Food and Drug Administration (FDA) clearance of its latest artificial intelligence (AI) software solution, PowerLook…
FDA clears first magnetic, noninvasive device treatment for OCD | Digital…
The FDA granted de novo clearance to the first noninvasive device treatment for obsessive compulsive disorder, Brainsway’s transcranial magnetic stimulation…
FDA clears first dual-lead nerve stimulator for pain relief | Digital…
The FDA granted clearance to SPR Therapeutics’ single- and dual-lead peripheral nerve stimulation devices as minimally invasive, non-opioid alternatives,…
FDA approves app as a form of birth control | Innovation & Feature
There have never been so many choices when it comes to birth control, and now the US Food and Drug Administration (FDA) has approved a ‘digital contraceptive’…
The FDA OK’d an app as a form of birth control | Startup
Breaking Tech Industry news from the top sources
Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just…
Certara modeling aided 95% drug approvals in the first half of 2018, as the…
Certara reported that its drug development software, including modeling and simulation services, supported 95% of the 20 novel drugs approved by the FDA in the…