Government

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.
GE Research selected DNA Script to join a collaboration working on a rapid response, mobile platform to develop on-demand production of nucleic acid-based vaccines and therapies related to biological threats.
Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
Cancer therapy company Athenex suffered a regulatory setback with the receipt of a complete response letter from the U.S. Food and Drug Administration.
PRESS RELEASES