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Branded Manufacturers Decline to Remove Patents From the Orange Book After Receiving Letters From the FTC

On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to their patent listings...more

FDA Issues Long-Overdue Regulations on Direct-To-Consumer Advertisements for Prescription Medications

On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more

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

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

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

Antisense Oligonucleotide SPINRAZA Wins FDA Approval

On December 23, 2016, the U.S. Food and Drug Administration approved SPINRAZA™ (nusinersen), an antisense oligonucleotide directed to survival motor neuron-2 (SMN2) transcripts for the treatment of spinal muscular atrophy...more

The PTAB May Be Taking a More Balanced Approach in Biotech and Pharmaceutical IPRs

Patent challengers were first able to file inter partes review (IPR) petitions on September 16, 2012. Since then IPRs have become an increasingly popular way of challenging the validity of patents. In the first three months...more

Biosimilars Webinar - July 23, 2013

On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more

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