FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...
Pharm Exec7d
FDA Approves Subcutaneous Form of Bristol Myers Squibb's Opdivo Qvantig for Multiple Solid Tumor Indications
The FDA has approved Bristol Myers Squibb’s (BMS ... RCC accounts for approximately nine out of 10 kidney cancer diagnoses, making it the most common form. In turn, eight out of 10 RCC diagnoses are ...
FiercePharma3d
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
Becker's Hospital Review13d
FDA rejects injectable form of J&J's lung cancer drug
After a priority review, the FDA did not approve an injectable form of Rybrevant, a Johnson & Johnson medication for non-small cell lung cancer. The rejection is not due to the therapy's ...
MassDevice3d
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.