Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Source: Drug Industry Daily

The FDA is reaching out to states that have filed applications with the agency seeking approval to directly import prescription medicines from Canada. Source: Drug Industry Daily

Alzheimer’s disease drug Aduhelm and other investigational anti-amyloid antibodies similar to Aduhelm will only be covered by Medicare and Medicaid if they’re used in the setting of a federally approved…

Generics and biosimilars will slow the overall pace of drug spending growth this year, even though U.S. prescription drug spending is slated to rise by 4 to 6 percent year-over-year…

The UK’s National Institute for Clinical Excellence (NICE) voted down a recommendation for Gilead Sciences’ chemotherapy drug aimed at triple-negative breast cancer, but approved Merck KGaA’s Bavencio (avelumab), which fought…

Pfizer announced yesterday that it would acquire ReViral in a $525 million deal that will give the company ownership of ReViral’s experimental treatments for respiratory syncytial virus (RSV) infections. Source:…

Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a…

Repeated COVID-19 boosters simply aren’t a practical way to deal with the shape-shifting SARS-CoV-2 virus, according to members of the FDA’s Vaccines and Related Biologics Advisory Committee. Source: Drug Industry…

Two draft guidelines from the International Council for Harmonization (ICH) were released yesterday for public comment, one on pediatric extrapolation in clinical trials and the other on calculating compound-specific acceptable…

The FDA issued a final guidance yesterday for sponsors of drugs and biologics for the treatment of chronic hepatitis B that expands upon a November 2018 draft. Source: Drug Industry…