Government
The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration.
For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals.
There were two reported cases of trials restarting and one pausing this week. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 2, 2021.
A spirit of urgency and collaboration broke down traditional informational barriers as industry and academia organized like never before in modern history to develop a vaccine in just nine months.
February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
The U.S. Department of Justice is set to recover more than $3 billion this year from pharmaceutical and medical device manufacturers as well as healthcare providers, labs and pharmacies found guilty of healthcare fraud under the False Claims Act.
The FDA is on a roll granting approvals. Three companies announced IND updates today.
A special fund for vaccine research that was set aside by the U.S. Department of Health and Human Services in 2010 has been misused to pay for unrelated expenses, a government report shows.
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