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February 08, 2022
With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.
February 07, 2022
The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.
A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.
February 04, 2022
The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).
February 01, 2022
CDMOs offer expertise and customization options for sponsors of orphan drugs.
January 31, 2022
The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products
January 28, 2022
NICE has updated its Technology Appraisal Guidance TA599 for AstraZeneca’s Lokelma.
January 26, 2022
Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.
January 19, 2022
The agency discusses its response to COVID-19 and other milestones in its year-end review.
The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.