Approvals
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.
The U.S. Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning.
The U.S. FDA has granted rare pediatric disease and orphan drug designations for Taysha Gene Therapies’ AAV9-based gene treatment candidate currently in development for epilepsy caused by SLC13A5 deficiency.
PRESS RELEASES