Tag Archive for: labeling

Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the US and EU in 2024. The detailed results from FLOW will be presented at a scientific conference in 2024.

This approval marks the third indication for Keytruda in cervical cancer and the 39th indication for Keytruda in the United States.

Despite failing to hit the primary endpoint in the Phase III EMBARK study, the company plans to file for a label expansion for its Duchenne muscular dystrophy gene therapy Elevidys.

In its complete response letter, the regulator asked AstraZeneca to improve Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) and include a background check for patients’ meningococcal vaccination status or require prophylactic antibiotic use before treatment.

Merck now faces a raft of lawsuits alleging it knew from its early research that the drug could impact the brain and that it minimized the potential for psychiatric problems in statements to regulators.

Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.

The justices turned away Israel-based Teva’s appeal of a lower court’s ruling reinstating the jury award for U.K.-based GSK. The case involves “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug’s label omits potentially infringing uses of a brand-name drug.

The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.

The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide.

Ardelyx, Inc. announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH