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In a draft guidance released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) offer advice for sponsors on the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Read More
Allergan has agreed to pay $200 million to resolve New York-based claims that it helped facilitate the state’s opioid crisis through deceptive marketing. Read More
The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune systems. Read More
The FDA offered guidance for sponsors of individualized drugs developed for use against life-threatening genetic diseases in two draft guidances released yesterday. Read More
Cutting prices for costly therapies approved under an accelerated pathway may not significantly reduce total prescription drug spending by Medicare, says a new study by researchers at Brigham and Women’s Hospital in Boston, Mass. Read More
Janus kinase (JAK) inhibitor anti-inflammatories made by Pfizer, AbbVie and Eli Lilly for inflammatory diseases, such as rheumatoid arthritis and ulcerative colitis, have all received the strictest warnings added to their labels by the FDA, which cited risk of serious health issues and the possibility of death in patients age 50 and over. Read More
President Biden delivered a speech yesterday highlighting the drug pricing reform measures in the Build Back Better Act — especially for insulin products — shortly after Sen. Majority Leader Chuck Schumer (D-N.Y.) released a letter outlining Democratic attempts to pass the $2 trillion bill by Christmas. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has issued two manuals for agency staff on user fees — one updated and one brand new. Read More
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Read More
The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Read More