Novartis says it is seeking revised prescribing information with Beovu (brolucizumab) after confirming a safety signal involving retinal vasculitis an...
FDA issues a guidance entitled Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders Not Registered as...
FDA issues a second emergency use authorization for decontaminating compatible N95 or N95-equivalent respirators for reuse by health care workers in h...
FDA approves an AstraZeneca NDA for Koselugo (selumetinib) for treating of pediatric patients with neurofibromatosis type 1, a nervous system genetic ...
FDA grants Vapotherm a breakthrough device designation for its Oxygen Assist Module for use in the companys Precision Flow system.
FDA directs industry to a new guidance from HHS Office for Human Research Protections entitled OHRP Guidance on Covid-19.
Rep. Donna DeGette calls on FDA to take several steps to ensure that patients who need hydroxychloroquine and chloroquine for approved indications can...
Medtronic describes several actions to increase its manufacturing of ventilators to help patients hospitalized with Covid-19.