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The U.S. Court of Appeals for the First Circuit said that it will not revive several hundred lawsuits accusing GSK of failing to warn female patients that its anti-nausea therapy Zofran (ondansetron) could induce birth defects. Read More
Otsuka and developmental partner Lundbeck have snagged FDA priority review of their supplemental new drug application (sNDA) for Rexulti (brexpiprazole) as a treatment for agitation in people with Alzheimer’s disease. Read More
In a move that could affect many drugmakers and their patient assistance programs, the U.S. Supreme Court has refused to take up Pfizer’s appeal that it should be able to offer a copay assistance plan to patients to help them pay for the company’s expensive heart medication. Read More
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee struggled to find definitive answers when it met Monday to consider dosing and labeling for Regeneron Pharmaceuticals’ aflibercept as a treatment for retinopathy of prematurity (ROP), a leading cause of childhood blindness. Read More
The vaccine demonstrated noninferiority in antibody response compared to Pfizer’s 20-valent pneumococcal conjugate vaccine Prevnar 20 in 20 serotypes, the company said. Read More
The European Medicines Agency (EMA) is the first regulator to adopt the International Council for Harmonization (ICH) new guideline Q13 on continuous manufacturing (CM) of drug substances and drug products, effective July 10, 2023. Read More
In the wake of the FDA allowing the so-called abortion pill to be dispensed via pharmacies, removing the requirement that the drug only be given to patients in a healthcare setting, the Center for Drug Evaluation and Research (CDER) has rejected two related citizen petitions — one to restrict use and the other to expand the indication. Read More
Novartis has agreed to pay $245 million in settlements to end antitrust cases that claimed the drugmaker delayed the launch of generic versions of its hypertension medicine Exforge (amlodipine and valsartan) in the U.S. market. Read More
Two final documents from the FDA outline a standardized structure and language for risk evaluation and mitigation strategy (REMS) documents to make them more clear and consistent and submissible in Structured Product Labeling (SPL) format. Read More