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Cancer FDA Approval Prescription Drugs

Stark & Stark

A Simple Guide to Depo-Provera Lawsuits and Settlements

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What is a meningioma and what types of injuries qualify? Depo-Provera has many known side effects. However, the current Depo-Provera litigation mainly involves a “signature injury” that was not properly warned against by...more

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

Goodwin on

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

Goodwin

FDA Approves New Biologic Cancer Treatments

Goodwin on

On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC...more

Womble Bond Dickinson

New blood test to guide personalized cancer treatment

Womble Bond Dickinson on

On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more

Searcy Denney Scarola Barnhart & Shipley

Did Patients Trade Weight Loss Concerns for Cancer Concerns? - BELVIQ

Is BELVIQ adding to patient cancer risks? In February of 2020, an announcement was made that the weight loss drug lorcaserin (sold under brand names BELVIQ and BELVIQ XR) would be voluntarily withdrawn from the market in...more

Foley & Lardner LLP

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

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The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more

Knobbe Martens

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

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On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

Knobbe Martens

FDA Approves Zelboraf for Treatment of a Rare Cancer

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On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

Knobbe Martens

Bayer Receives Accelerated Approval for Aliqopa

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On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more

Knobbe Martens

FDA Approves Keytruda as First Cancer Treatment Based on a Genetic Biomarker

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The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more

Knobbe Martens

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

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On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more

Miles & Stockbridge P.C.

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

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