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Jones Day

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

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The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more

Holland & Knight LLP

FDA Rejects Application for Psychedelic Drug

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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

Husch Blackwell LLP

Employer Vaccine Update: As FDA Reviews Vaccines, Drug Makers Report Limited Supplies

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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

Goodwin

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO

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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

King & Spalding

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

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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

Goodwin

FDA Advisory Panels Considering Approvals of Two Biosimilars This Week

Goodwin on

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

Goodwin

FDA Announces Advisory Committee Meeting on Sandoz’s Etanercept Biosimilar

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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

Foley & Lardner LLP

FDA Panel Shows Strong Support for a Remicade Biosimilar

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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

BakerHostetler

FDA Committee to Continue Considering Drug Compounding Issues

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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

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