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March 29, 2021
Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
March 24, 2021
The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.
March 23, 2021
FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.
March 19, 2021
MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.
BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.
March 16, 2021
March 15, 2021
The agency’s focus appears to be on generic drugs for the upcoming year.
Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.
With no final nomination of FDA commissioner coming from the White House, concern has mounted among regulated industry and interested stakeholders that FDA operations and stature will suffer without a permanent commissioner able to articulate new policies and gain support for innovative programs.