Government

FDA
The drug is a lipoglycopeptide antibiotic. It is given in a single, one-hour infusion.
With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
It has been one year since COVID-19 was declared a global pandemic. In that time, more than 118 million people have contracted the virus and 2,622,190 people, including 529,267 in the United States, have died as a result.
According to the Centers for Disease Control and Prevention, more than 35,000 Americans perish each year from antibiotic-resistant infections, and estimates have AMR claiming the lives of as many as 10 million globally by 2050.
With no permanent commissioner, the U.S. Food and Drug Administration appears to be both cracking down on Accelerated Approvals while struggling with a backlog of inspections.
In the wake of an increasingly accelerated COVID-19 vaccine rollout, the CDC has released new guidance statements that give fully vaccinated individuals more freedom to socialize and participate in pre-pandemic activities.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.
The Russian government is attempting to cast a negative light on the COVID-19 vaccine developed by Pfizer and BioNTech, as well as other vaccines, in order to boost sales of its own vaccine, Sputnik V, the government charged.
FDA
KemPharm announced this week that the U.S. Food and Drug Administration has approved its novel ADHD drug for use in patients six years and older.
Advocates from the ALS community flooded the FDA with letters, Tweets, emails, videos and other comments expressing their anger over the rejection and the frustration that there are few therapeutics for a disease that is a delayed death sentence.
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