News & Analysis as of

Healthcare › Clinical Trials › FDA Approval

Robins Kaplan LLP

Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC

Robins Kaplan LLP on

Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 2025 WL 1298920 (Fed. Cir. May 6, 2025) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from...more

Foley & Lardner LLP

GLP-1 Receptor Agonists: Clinical Trial Considerations

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®). Although...more

Pullman & Comley - Connecticut Health Law

A Progress Report on Psychedelic Drug Legislation in Connecticut and Nearby States

Pullman & Comley - Connecticut Health Law on

The burgeoning field of psychedelic medicine, which suffered a major setback last year when the Food and Drug Administration (FDA) rejected an application to approve the use of midomafetamine (MDMA) to treat post-traumatic...more

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

Fenwick & West LLP on

Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

Knobbe Martens

An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial

Knobbe Martens on

Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t...more

Epstein Becker & Green

Unpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance

Epstein Becker & Green on

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more

Knobbe Martens

FDA Approves Neuralink to Begin Human Trials of Brain Implants

Knobbe Martens on

Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device.  Recruitment for...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide