Approvals
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Bristol Myers picked up the therapy when it acquired Celgene in 2019 for $74 billion.
It was a busy week for clinical trial updates. Here’s a look.
Johnson & Johnson’s Janssen Biotech submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its single-dose COVID-19 vaccine.
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.
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 FDA is on a roll granting approvals. Three companies announced IND updates today.
The U.S. Food and Drug Administration gave the green light to Aurinia’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for LN.
The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed.
PRESS RELEASES