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After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Read More
Semaglutide treatment of overweight or obese individuals does not increase the risk of developing depression or suicidal thoughts or actions, a team of researchers in the US, UK and Denmark reported. Read More
After receiving reports of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies, the agency has announced an investigation into the issue and is evaluating the need for regulatory action. Read More
FDA Commissioner Robert Califf said he believes the FDA can take steps to improve the current system for postmarket evaluation of drugs and make major renovations that address its current complexities and redundancies. Read More
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more. Read More
Bayer is issuing a voluntary withdrawal of Aliqopa (copanlisib) after the PI3K inhibitor failed to meet the primary endpoint of progression-free survival in its postmarketing confirmatory trial. Read More
The updated labeling says healthcare providers should tell patients that taking antithrombotic or thrombolytic medications with Aduhelm may increase the risk of bleeding in the brain. Read More