The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more
The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more
The Federal Circuit has recently provided substantial guidance on whether printed publications include documents publicly available via the internet. This article reviews four such cases that illustrate the expansive view...more
The FDA could approve two COVID-19 vaccines within a matter of days. However, drug makers have tried to keep expectations in check about how much vaccine they can deliver immediately and over the next few months as they...more
In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more
California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more
Companies that sell products or services that cannot be marketed without regulatory preclearance, and particularly companies that develop experimental drugs and medical devices, should take note of the recent opinion by Judge...more
Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more
France Bans Meat and Dairy Terms for Plant-Based Foods - The French Parliament has reportedly voted to prohibit the use of meat and dairy terms to describe plant-based substitutes such as vegetarian sausage or vegan bacon....more
Spurred by a challenge from Public Citizen last year, the Food and Drug Administration announced recently that it will no longer redact information from the curricula vitae (CV) of advisory committee members. Current advisory...more
The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is...more
An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s...more
We previously reported on Sandoz’s aBLA for a biosimilar of Amgen’s ENBREL (etanercept) and the related BPCIA litigation. The FDA’s Arthritis Advisory Committee announced this morning that it will hold a public advisory...more
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more
The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access...more