News and Analysis
Innovation, Technology, and IP News
Prosecution History May Support a Motivation to Combine
Written by: Rhett D. Ramsey & Jacob R. Rosenbaum Elekta Limited v. Zap Surgical Systems, Inc. Before: Reyna, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board. ...
Landmark CAFC Cases in Patent Law: Shaping the Future of Innovation
In the ever-evolving landscape of patent law, the Court of Appeals for the Federal Circuit (CAFC) has played a pivotal role in shaping the rules and precedents governing intellectual...
FDA Releases Draft Guidances on 510(k) Submissions
Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated...
IPR Decision Based on a Barely Mentioned Typo Violated the APA Notice Requirement
Written by:Brianne M. Kingery & Daniel Kiang APPLE INC. v. COREPHOTONICS, LTD. Before Stoll, Linn, and Stark. Appeal from the Patent Trial and Appeal Board. Summary: An IPR...
Feed tagged as "fda":
Medtronic, Inc. is developing a new stent graft system designed to repair thoracic aortic aneurysm. It has been selected by the FDA for an early feasibility pilot... Read More »
The US Food and Drug Administration (FDA) today issued three draft guidance documents on biosimilar product development to assist industry in developing these... Read More »
Two new blood thinners, Xarelto (rivaroxaban) and Pradaxa (dabigatran etexilate) have been approved by the FDA for patients with atrial fibrillation that is not... Read More »
Pfizer announced that the U.S. Food and Drug Administration has approved their kidney cancer drug INLYTA (axinib). The treatment will be available for patients... Read More »
Amgen announced today that the FDA has agreed to modify the requirements of the Nplate® Risk Evaluation and Mitigation Strategy Program (REMS). When reviewing the ... Read More »
Boston Scientific announced its next-generation drug-eluting stent was approved by the Federal Food and Drug Administration. With it’s innovative platinum... Read More »
CHICAGO (Reuters) - An experimental drug that chokes off the blood supply to fat cells helped obese monkeys slim down, a sign that it may work in people... Read More »
Two major pharmaceutical companies, Amylin Pharmaceuticals Inc (“Amylin”) and Eli Lilly and Company (“Lilly”), announced today their plans to... Read More »
(Reuters) - U.S. health regulators approved on Friday the stroke preventer Xarelto from Bayer AG and Johnson & Johnson for people with a common heart rhythm... Read More »
On October 31st, the company Medtronic received US Federal Food and Drug Administration approval to treat Narrow Iliac arteries with the use of the Cobalt Chromium... Read More »
Medtronic Inc has developed a new device for the treatment of peripheral artery disease. This new FDA approved device, dubbed the Assurant Cobalt... Read More »
On August 25, 2011 Johnson & Johnson Pharmaceutical Research and Development, L.L.C (J&JPRD) received approval from the US Food and Drug... Read More »
CHICAGO (Reuters) - Stimulants used to treat attention deficit hyperactivity disorder do not increase the risk of heart attacks, strokes or sudden death, U.S... Read More »
By Andrew M. Seaman
NEW YORK (Reuters Health) - An international survey of cancer doctors shows... Read More »
(Reuters) - U.S. device reviewers said a Medtronic Inc device was effective for treating a common heart rhythm disorder, but raised concerns about its safety... Read More »
By Jim Finkle
BOSTON (Reuters) - Medtronic Inc has asked software security experts to investigate... Read More »
(Reuters) - Smokers who take Pfizer's pill Chantix to help them quit do not have a higher risk of being hospitalized for psychiatric events such as... Read More »
(Reuters) - Exelixis Inc's drug to treat a rare form of thyroid cancer met the main goal of a late-stage study, prompting the company to look to an... Read More »
