Healio9h
FDA approves subcutaneous Merilog for glycemic control in diabetes
The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog ...
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under ...
Managed Healthcare Executive11h
FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult ...
Healio14h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Health groups sound alarm on missing CDC, FDA data
Prominent health care organizations urge the Trump administration to restore important data sets on the Centers for Disease ...
Targeted Oncology3d
FDA Grants 510(k) Clearance to Ibex Prostate Detect AI for Prostate Cancer
The FDA has granted a 510 (k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read). The Ibex Prostate ...
USA Today14d
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release. The medication will ...
Managed Healthcare Executive1d
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
Pharm Exec3d
FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be ...
Pharm Exec9d
FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus
The FDA has granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy, for ...
FiercePharma1d
Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...