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CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he was a vice president at Merck Research Laboratories and formerly a vice president at Janssen. Read More
The White House said Thursday that it will ask the U.S. Supreme Court to step in to defend the FDA’s 22-year-old decision to approve the abortion drug mifepristone after an appeals court denied the Justice Department’s request to allow full access to the drug on Wednesday. Read More
Bristol Myers Squibb (BMS) and Pfizer have together filed separate lawsuits against two generic drugmakers, seeking to prevent the release of generic versions of Eliquis (apixaban), the blockbuster anticoagulant the pharma giants jointly developed. Read More
Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) and Vertex Pharmaceuticals’ exagamglogene autotemcel (exa-cel) gene therapies for severe sickle cell disease (SCD) would probably be cost-effective if priced around $2 million, according to a draft review by the Institute for Clinical Evaluation and Research (ICER). Read More
The FDA offers several pathways to expedite approval of new drugs to help get them to market much more quickly while still evaluating their safety. Read More
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