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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
“The company has already instituted additional quality controls and expects to be able to consistently reduce NTTP levels to meet the long-term acceptable daily intake level this year,” Merck said. Read More
After a potential carcinogen, Nitroso-STG-19 (NTTP), was found in samples of Merck’s sitagliptin-containing diabetes drugs, the New Jersey drugmaker says it has identified the root cause of the nitrosamine impurity and hopes to fix the issue this year. Read More