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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
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
A study of drugs granted accelerated approval by the FDA between January 2012 and July 2021 found that more than half of the required confirmatory trials missed their deadlines. Read More
The Center for Biologics Evaluation and Research (CBER)’s ability to hire and retain staff will be a key challenge for fiscal 2024, according to Peter Marks, the center’s director, who spoke last week at an Alliance for a Stronger FDA webinar. Read More
A federal appeals court has cleared the way for PhRMA’s complaint against Minnesota’s plan to have manufacturers provide insulin for free to move forward. Read More
The FDA has withdrawn its approval of Makena, Covis Pharmaceutical’s drug to reduce the risk of pre-term birth in at-risk women, citing the lack of a favorable postmarket benefit-risk assessment and ending Covis’ hopes for an “orderly wind-down” period. Read More
Arbutus Biopharma and Genevant Sciences have filed a complaint in a federal court alleging that Pfizer and BioNTech violated five patents related to their messenger RNA (mRNA) delivery technology used in the Pfizer/BioNTech COVID-19 vaccine. Read More