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Arbutus Biopharma — which has been going after makers of the two messenger RNA (mRNA)-based COVID-19 vaccine makers alleging patent infringement — suffered a loss this week when a U.S. appeals court affirmed a decision to cancel its patent related to Moderna’s vaccine. Read More
Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles such as a high failure rate and proof of efficacy stand in the way of wider adoption. Read More
Upcoming events in the coming weeks include nine FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
New FDA drug approvals in the past month include treatments for rare diseases and an aggressive form of skin cancer, as well as the first new treatment for invasive fungal infections in over a decade. Additionally, the FDA approved a new device for use in patients with arterial occlusive disease. Read More
The drug candidate is being evaluated in a phase 1 study in patients with advanced metastatic or progressive solid tumors who are either resistant to or can’t tolerate the standard therapy. Read More
The FDA offers expanded advice for sponsors on risk-based monitoring of clinical trials in a new final guidance that updates the agency’s previous guidance on the topic issued in 2013. Read More
While Congress may have ended the “national emergency related to the COVID-19 pandemic” with a joint resolution President Biden signed into law on Monday, the public health emergency (PHE) declared by HHS Secretary Xavier Becerra will remain in effect another month. Read More
Right now, the dual orexin receptor antagonist class of chronic insomnia medications is a scheduled class under the Controlled Substances Act. Read More
As two dueling lawsuits over the FDA-approved medical abortion drug mifepristone appear headed to the U.S. Supreme Court, hundreds of drugmakers say Friday’s ruling in the Texas case is an overstep that could weaken the federal agency and hamper future drug development. Read More
In an effort to increase industry dialogue around best practices for benefit-risk assessments, AstraZeneca (AZ) has publicly shared the structured benefit-risk (sBR) assessment framework it employs across its drug development process. Read More