Articles related to FDA

The FDA announced a trial hold after two participants with sickle cell disease (SCD) in the LentiGlobin gene therapy trials developed AML and MDS. According to bluebird bio, the manufacturer of LentiGlobin products, the company was unable to find any cancer cells in the patient’s bone marrow and has asked the FDA for permission to resume clinical trials.

The approval of the drug (Fotivda, Aveo Pharmaceuticals) was based on the results of the open-label, multi-center TIVO-3 trial, which looked at progression-free survival (PFS) as the main efficacy endpoint, assessed by a blinded independent radiology review committee. Secondary end points included overall survival (OS) and objective response rate (ORR).

More good news for zanubrutinib, which received accelerated approval in November 2019 in the US for the treatment of mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. The supplemental new drug application (sNDA) was submitted by the drug’s manufacturer, BeiGene, based on data from the global phase III ASPEN trial.

As of February 8, 2021, more than 31 million people in the U.S. had received at least one dose of the coronavirus vaccine, with 36 cases of immune thrombocytopenia (ITP) reported to the Vaccine Adverse Event Reporting System by the end of January. Is the onset of the condition related to the vaccines? The vaccines are considered safe overall, but what did the CDC and FDA have to say about it?

Despite the COVID-19 pandemic seemingly putting a hold on everything, approvals of new drugs have not waned. In fact, despite their high price tags – median prices ranged from $766 million to $2.8 billion – new drugs continue to roll out in 2021. Here are five new drugs approved this year that you may find useful in your clinical practice of medicine.

This drug was first approved in the US in the 1970s for anesthesia and pain relief, and last year, the FDA approved it for patients with major depression that are treatment resistant. If you said ketamine, you’re correct, and because more than 30% of patients are resistant to SSRIs, finding an effective treatment for major depressive disorder is challenging. Could this old drug be the answer?