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An international group of university students devoted to advancing health equity and access to therapies has filed a citizen’s petition seeking heightened efforts to improve compliance with clinical trial reporting requirements — yet another call for the FDA to step up enforcement in this area. Read More
A bill that would prevent pharma companies from blocking generic competition by patenting their drugs’ Risk Evaluation and Mitigation Strategy (REMS) programs is making a return appearance in the 118th Congress. Read More
In its latest annual report on drug safety priorities, the FDA’s Center for Drug Evaluation and Research (CDER) highlighted the agency’s continued focus on COVID-19 products and its commitment to safety around opioids. Read More
The FDA’s Office of Generic Drugs (OGD) approved 742 abbreviated new drug applications (ANDA) in 2022 compared with 663 the previous year, according to OGD’s latest annual report. Read More
An FDA advisory committee unanimously agreed yesterday that GlaxoSmithKline’s investigational vaccine Arexvy (RSVPreF3-AS01E) is effective in preventing lower respiratory tract disease associated with respiratory syncytial virus (RSV) infections in people age 60 years and older. Read More
An FDA advisory committee has cleared the way for Pfizer’s investigational respiratory syncytial virus (RSV) vaccine, Abrysvo (RSVpreF) — a likely blockbuster product for Pfizer if approved. Read More
Billy Dunn, director of the FDA’s Office of Neuroscience (ON) and a key figure in the FDA’s controversial June 2021 approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), is officially leaving the agency after nearly two decades. Read More