The agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for hospitalized patients 12 years and over diagnosed with the virus.
As the pandemic maintains its hold, the US agency continues to issue advice and take action related to testing, treatment and information on the virus.
The US agency continues to issue advice for life-sciences professionals engaged in work related to the virus, and keep an eye out for fraudulent products.
The agency continues to offer advice to pharma industry professionals during the global public health crisis, and offer advice on developing solutions.
After receiving FDA approval, the pharmaceutical company has announced plans to launch a Phase I trial for an inhaled version of the COVID-19 treatment.
The federal agency continues to aid drug developers, trial teams and the public with advice and actions related to the virus behind the global pandemic.
The agency continues to offer advice related to drug development and clinical research during the pandemic, and take action against those falling out of line.
The federal agency continues to monitor as the virus impacts the pharma and clinical trials industries, offering advice and taking action where necessary.
A representative of the life-sciences consulting firm outlines how the federal agency has reacted to the COVID-19 pandemic, and how it might advise the industry going forward.
The federal agency continues to offer advice for healthcare and pharma industry professionals, and to take action against companies acting out of bounds.
Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.
Aiming to encourage entry of generic drugs on the market, the US FDA published a finalized guidance that regulates processes for relevant designations and expedited approvals.
Spaulding has been contracted by the US FDA to support clinical trials in various therapeutic areas for the following five years, starting with a $5m reward for the first year.
The US FDA announces shortage of a drug due to a site affected by coronavirus, as it focuses on the protection of the supply chain from outbreak impacts.
US FDA’s 2019 Drugs Trials Snapshots show female participation in clinical trials of the drugs approved during the past year increased, although ethnic diversity remains an issue.
