As we begin the first month of the year 2020, it’s time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision.
Forty-eight *novel drugs and biologics received FDA approval in 2019 compared to an all-time high of 59 in 2018. The only other time when the approval tally was above 50 was in 1996 – with 53 approvals.
February is just around the corner. It's that time to take a look back at some of the top news stories of January and look ahead at what's coming next over the horizon on the regulatory front.
A topic that has been making headlines globally is the coronavirus. On December 31, 2019, China alerted the WHO to several cases of pneumonia caused by a new coronavirus in Wuhan City, Hubei Province.
Wuhan, the Chinese city home to over 11 million people, was shut down on January 1, 2020. With the virus spreading at an accelerated space, China has now shut down nearly 13 cities to contain the virus spread. As per the latest update, 4,515 people have been infected with coronavirus and the death toll in China due to this virus outbreak has crossed 100.
In the United States, 5 confirmed cases of coronavirus have been reported, and all the 5 patients had recently traveled to Wuhan, China, the epicenter of coronavirus outbreak.
*Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.