Healio8h
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 ...
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 ...
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 ...
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 ...
dvm36010h
Laverdia-CA1's field trial ends, statistical analysis to begin
Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the ...
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 ...
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 ...
Oysters in Georgia recalled for possible norovirus contamination
The FDA is advising restaurants and food retailers not to serve or sell, and to dispose of oysters harvested from parts of ...
PharmExec3d
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 ...
Fierce Pharma1d
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 ...
Moderna Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Updates
Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizing ...