The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.
The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...
FDA staff return to crowded offices, broken equipment and missing chairs
WASHINGTON (AP) — Thousands of employees returned to the Food and Drug Administration’s headquarters Monday to find ...
FDA warns of misuse of laughing gas sold in colorful, flavored canisters
U.S. health officials are tracking a rise in injuries tied to the misuse of nitrous oxide, or laughing gas, including some ...
Down 62%. Should You Buy TransMedics Stock on the Dip?
Outside of the U.S., where OrganOx has a larger footprint, livers account for about 1% of TransMedics Group's sales. If ...
Food Safety News10d
FDA employees now lack the tools to do their jobs
Many critical functions of the food division of the Food and Drug Administration have been drastically slowed or entirely stopped since late ...
health.wusf.usf.edu10d
$25,000 buyout offered to most HHS employees, including those at the CDC, NIH and FDA
Most of the 80,000 workers responsible for researching diseases ... and the National Institutes of Health as well as the Food ...
FDA Says Drug, Device Reviewers Ineligible for $25,000 Buyout
The FDA told its staff Monday that employees responsible for reviewing drugs, medical devices, and tobacco products aren’t ...
Ophthalmology Times10d
OKYO Pharma files application for Fast Track designation with the FDA for urcosimod for the treatment of neuropathic corneal pain
Urcosmid is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune ...
C&EN13d
FDA nominee Marty Makary outlines vision for improving public health
President Trump’s pick to lead the US Food and Drug Administration tells senators he will follow science and common sense ...
FDA nominee sidesteps questions on abortion pill, agency layoffs and other issues
Dr. Marty Makary is largely sidestepping Senate questions about his plans to lead the Food and Drug Administration ...