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 ...
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 ...
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 ...
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 ...
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).
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 ...
MedCity News9d
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 ...
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 ...
The American Journal of Managed Care7d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
Managed Healthcare Executive7d
FDA Approves Journavx, New Nonopioid Med, for Acute Pain
The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid ...