Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
Targeted Oncology1d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Hosted on MSN32m
Senseonics files for Eversense 365 CE Mark registration
Completing the CE Mark submission for Eversense 365 brings us a step closer to improving lives and health outcomes for ...
The American Journal of Managed Care3d
FDA Approves First Subcutaneous Apomorphine Device for Parkinson Disease
The FDA has approved the first and only subcutaneous apomorphine infusion device, apomorphine hydrochloride injection (Onapgo ...
FDA approves Susvimo for diabetic macular edema
The U.S. Food and Drug Administration has approved Genentech's Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular ...
The American Journal of Managed Care3d
FDA Approves Ranibizumab Implant in Treatment of DME
The ranibizumab injection could be administered in a convenient schedule twice per year for the treatment of diabetic macular ...
Healio4d
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
Pharm Exec12d
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
The FDA has approved a Supplemental Biologics License Application (sBLA) for intravenous maintenance dosing of Eisai and Biogen’s Leqembi (lecanemab) once every four weeks for patients with early ...
Zacks.com on MSN10d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
FDA approves new type of non-opioid pain medication
The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class ...
Time on MSN4d
FDA Approves the First Non-Opioid Pain Drug in 20 Years
The prescription pills, sold under the brand name Journavx and made by Vertex Pharmaceuticals, are taken twice a day and ...
USA Today7d
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage ...