Agile Therapeutics Inc. didn't feel much love Wednesday from FDA reviewers who questioned the efficacy of its Twirla birth control patch, but it got a warm embrace from the Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-1, with one abstention, that Twirla's benefits outweigh its risks.
FDA approval of Vumerity (diroximel fumarate), a new therapy for people with multiple sclerosis (MS) offering improved gastrointestinal tolerability over Tecfidera (dimethyl fumarate), marks a win for its co-developers, Biogen Inc. and Alkermes plc, while triggering a $150 million payment from Biogen to its partner to mark the milestone. Biogen will also pay Alkermes a royalty on worldwide sales of the product.
The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.
LONDON – The World Health Organization (WHO) aims to hit back at anti-vaccination campaigners and take a role in ensuring the safety of consumer-targeted health apps, as part of a broader push to exert more influence in shaping digital technologies to meet global public health needs.
The FDA's guidance for uncertainty of benefit-risk provided some clarity on the benefit-risk question, but the terms of the "uncertainty" guidance could apply to the agency's Safer Technologies Program (STeP) despite that the STeP program applies to 510(k) devices, which are excluded from the scope of the uncertainty guidance.
Surmodics Inc., of Eden Prairie, Minn., said the U.S. FDA has granted a breakthrough device designation to its Sundance sirolimus-coated balloon (SCB) catheter to potentially help those suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.
Los Altos, Calif.-based Heartvista Inc. has received the U.S. FDA's nod for its One Click autonomous MRI acquisition software for cardiac exams. The company said that One Click is the first artificial intelligence (AI)-assisted solution designed specifically with the goal of enhancing the performance and results of cardiac MRI scans.
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