News

Fierce Pharma2h
After Hetlioz’s rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use
After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...
US FDA approves syringe version of Argenx's immune disorder drug
The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...
US FDA to phase out animal testing in drug development
The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal ...
Novartis announces planned $23B investment over five years in U.S.
Novartis (NVS) announced a planned $23B investment over five years in U.S.-based infrastructure, ensuring all key Novartis medicines for U.S.
Cabot Creamery recalls 1,700 pounds of butter due to possible fecal contamination
About 1,700 pounds of its Cabot Creamery butter are being recalled due to contamination with a particular bacteria that may ...
STAT1d
Pharmalittle: We’re reading about the FDA closing generic drug office, its U-turn on remote work, and more
A FDA generic drug office was eliminated — and the implications will be felt not only by drugmakers, but consumers ...
STAT1d
Why the closure of an FDA office may impact generics manufacturers — and everyday Americans
The Division of Policy Development in the Office of Generic Drug Policy, which was created more than a decade ago, was ...
People14d
FDA Issues Recall for Coffee Grounds in 15 States
Earlier this month, the FDA issued a recall on over 75,000 bottles of two International Delight Coffee Creamers. Danone, LLC, the parent company of the brand, reported receiving complaints of “s ...
TMJ4 News WTMJ-TV15d
FDA recalls over 10,000 cans of Coca-Cola sold in Wisconsin and Illinois
More than 10,000 cans of Coca-Cola sold in Wisconsin and Illinois have been recalled over possible plastic contamination.
Roll Call15d
Targeting FDA user fees would leave agency gutted, experts say
Health and Human Services Secretary Robert F. Kennedy Jr. and his allies rallied around removing industry influence from the Food and Drug Administration as part of their quest to Make America ...
FDA approves first new antibiotic for UTIs in nearly 30 years
The drug Blujepa, from drugmaker GSK, provides a new treatment option as bacteria increasingly become resistant to the ...