Regulatory
The goal is to “identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 16, 2021.
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.
Sanofi and Regeneron Pharmaceuticals’ checkpoint inhibitor Libtayo performed so well that the regulators anticipate that the trials may need to be halt early.
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.
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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