Pharm Exec3d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
JD Supra5h
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 ...
Ozempic Approved By FDA For Kidney Disease—In Ultra-Popular Drug’s Latest Approval
Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the risk of heart attacks and ...
Targeted Oncology2d
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 ...
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 ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
Vertex Pharma Stock Surges After FDA Approves Non-Opioid Pain Drug
Analyst is bullish on Vertex Pharmaceuticals, citing FDA approval for JOURNAVX and strong earnings growth potential in 2025.
GlobalData on MSN9d
Novo Nordisk secures FDA approval for Ozempic in diabetes with CKD
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks ...
Supernus announces U.S. FDA approved an update for label for Qelbree
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has approved an update for the label for Qelbree to ...
MedCity News10d
New FDA Approval Adds Chronic Kidney Disease to Ozempic’s Label
and Novo Nordisk can now claim to have the first medication in this class approved for chronic kidney disease. The FDA has expanded the label of Ozempic, approving the Novo Nordisk product for ...
Nasdaq11d
FDA Approves Qelbree Label For ADHD And Lactation
(RTTNews) - Supernus Pharmaceuticals, Inc. (SUPN), a biopharmaceutical company, announced on Monday that the U.S. Food and Drug Administration or FDA has approved an updated label for Qelbree or ...
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).