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Today's Popular Updates › FDA Approval

A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Goodwin

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Foley & Lardner LLP

Substance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage

Foley & Lardner LLP on

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more

Goodwin

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

Goodwin on

​​​​​​​On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more

Fish & Richardson

Biologics and Biosimilars Landscape: IP, Policy, and Market Developments

Fish & Richardson on

In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Three Interchangeable Biosimilar Drugs in 2024

McDonnell Boehnen Hulbert & Berghoff LLP on

After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: FDA Approves First Gene Therapies for Sickle Cell Disease

Rothwell, Figg, Ernst & Manbeck, P.C. on

In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more

Goodwin

Genentech and Biogen File Joint Stipulation of Dismissal in BPCIA Litigation Regarding Tocilizumab

Goodwin on

​​​​​​​As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions,...more

Arnall Golden Gregory LLP

[Webinar] FDA Tries to Keep Up: How FDA and Industry Are Trying to Keep Up With Artificial Intelligence - September 13th, 2:00 pm...

Arnall Golden Gregory LLP on

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more

Knobbe Martens

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

Knobbe Martens on

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

Burr & Forman

Hot Topics in Health Care July 2023  

Burr & Forman on

Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

Husch Blackwell LLP

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Husch Blackwell LLP on

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Gardner Law

Are you Submission Ready? FDA Medical Device Submission Tips & Tricks

Gardner Law on

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Pillsbury Winthrop Shaw Pittman LLP

FDA Regulatory Approvals as the U.S. Emerges from the Immediate COVID-19 Emergency

Pillsbury Winthrop Shaw Pittman LLP on

Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more

Skadden, Arps, Slate, Meagher & Flom LLP

Securities Litigation and Regulatory Enforcement Update

Skadden, Arps, Slate, Meagher & Flom LLP on

On December 8, 2020, Skadden held the fourth and final installment of its annual Securities Litigation and Regulatory Enforcement Update, “Developments and Trends in Securities Litigation: A Year-End Update for 2020 and a...more

Epstein Becker & Green

[Virtual Briefing] Bias in Artificial Intelligence: Legal Risks and Solutions - March 23rd, 1:00 pm - 4:00 pm ET

Epstein Becker & Green on

You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more

Morgan Lewis

COVID-19 Vaccine: Considerations for UK Employers

Morgan Lewis on

The eagerly anticipated news of coronavirus (COVID-19) vaccine candidates last week has been welcomed by the scientific community across the globe. For employers, the news has prompted consideration of the potential...more

Goodwin

EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

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Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more

Perkins Coie

Ninth Circuit Rejects Securities Fraud Thesis That Did Not “Make a Whole Lot of Sense”

Perkins Coie on

In its June 10, 2020, opinion in Nguyen v. Endologix, the U.S. Court of Appeals for the Ninth Circuit applied the plausibility standard to a plaintiff’s securities fraud claims and affirmed the district court’s dismissal,...more

Goodwin

FDA Approves NDA for Semglee (insulin glargine injection)

Goodwin on

Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.  Semglee’s amino acid...more

Seyfarth Shaw LLP

The Week in Weed: June 2020

Seyfarth Shaw LLP on

Louisiana is expanding medical marijuana, and the United Nations may reschedule cannabis.  Meanwhile, PetSmart faces a lawsuit over pet CBD.  MedMen has campaign finance problems, and the 9th Circuit looks at taxes....more

Goodwin

Pfizer Announces Launches and Pricing Information for Three U.S. Biosimilars

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Today, Pfizer announced that it has launched or is launching the following three biosimilars in the United States at the following prices...more

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