This Week at the FDA: Cybersecurity and Roche’s Hemophilia Approval

Happy October, everyone!

We hope everyone’s enjoying this new ~fall weather~ and the endless supply of pumpkin spice flavored food products. This week, we’re highlighting four FDA announcements we think you should  hear about.

Check them out below!

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

In this age where cybersecurity is such a hot topic, it’s hard to figure out whether or not your data and devices are safe. It’s important for the FDA its role and its duties to protect the patients it serves– check out Scott Gottlieb’s public statement on the matter.

FDA approves Roche’s Hemlibra for haemophilia A without factor VIII inhibitor

Roche is making its way further into the hemophilia-space with this latest FDA approval.

Arikayce® Granted Accelerated Approval by the FDA for the Treatment of MAC Lung Disease

Technically, this came out last Friday, but we wanted to make sure everyone knew about the accelerated approval for a rare lung disease treatment.

Are trials for rare treatments including the patient voice enough? Later this month, hundreds of experts will gather to discuss this.


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