EMA Starts Review of Dexamethasone as COVID-19 Treatment
The European Medicines Agency (EMA) has announced in a July 24, 2020 press release that it has started a review of dexamethasone as a treatment […]
The European Medicines Agency (EMA) has announced in a July 24, 2020 press release that it has started a review of dexamethasone as a treatment […]
Kite, a Gilead Company, announced on July 24, 2020 that FDA granted accelerated approval to Tecartus (brexucabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy […]
A surge in applications to test and develop new cellular and gene therapies is overwhelming staff at FDA s Center for Biologics Evaluation and Research […]
As the world waits anxiously for more effective COVID-19 treatments and for a vaccine to halt the pandemic, analysts on all sides are examining appropriate […]
FDA announced in July that it plans to resume inspections of some US-regulated facilities this week, but it s not clear how it will decide […]
Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second […]
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that […]
FDA announced on July 10, 2020 that it was planning to restart inspections of domestic facilities the week of July 20, dependent on the trajectory […]
With more than 100 vaccine research programs looking to address the pandemic, FDA officials are moving to clarify standards and requirements for vetting and approving […]
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