FDA food label proposal could help Americans' health, UVA dietician says
The front-of-package labels could help consumers identify how ingredients in foods can be a part of a healthy diet.
JD Supra1d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
No-Moat Lundbeck's Strategic Brands Drive Growth but Face Generic Pressure Amid Patent Losses
However, we still see areas of weakness in the portfolio, including upcoming patent losses and a highly uncertain pipeline due to the complexities of running CNS trials. Historically, the firm ...
Eli Lilly's Recently Approved Inflammatory Bowel Disease Drug Shows Sustained And Durable Treatment At Two Years
Eli Lilly And Cao (NYSE:LLY) announced the results from the VIVID-2 open-label extension study of Omvoh (mirikizumab-mrkz).
Medscape2d
Some Patients — And Doctors — Turn to Microdosing GLP-1s
Advocates say microdosing reduces costs and side effects while maintaining weight loss, then can help with weight maintenance ...
Targeted Oncology3d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
oncnursingnews3d
T-DXd Companion Diagnostic in HER2-Ultralow Metastatic Breast Cancer Gains FDA Approval
The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
FiercePharma4d
Roche gains label expansion for eye implant Susvimo to treat diabetic macular edema
Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened ...
Librela U.S. label update ‘better than feared’ for Zoetis, says Morgan Stanley
Morgan Stanley analyst Erin Wright views the latest label change for Librela as “encouraging,” offering vets clarity in prescribing, and while ...
dvm3604d
Drug label is updated for pain management therapy
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
kffhealthnews4d
FDA OKs Pig Organ Transplant Studies For Those With Kidney Failure
The organs will come from genetically modified pigs in the hopes of helping the thousands of Americans waiting for transplants. Also in the news: the world's smallest heart pump, nanoplastics in the ...