FDA increases risk level of granola bar recall due to ‘adverse health’ effects
FDA increases risk level of granola bar recall due to ‘adverse health’ effects - The recall was first issued in December ...
Healio17h
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 ...
Healio23h
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 Executive19h
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 ...
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 ...
KTTV12d
FDA recalls breadcrumbs sold nationwide
The unseasoned bread crumbs were sold at stores throughout the United States from April 10, 2024, through Jan. 22, 2025, said ...
Targeted Oncology4d
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 ...
FiercePharma2d
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 ...
Senators call on FDA to act against misleading weight-loss drug commercials
Commercials run by the telehealth company Hims & Hers have been placed under the microscope as lawmakers are calling out the advertisement of prescriptions for injectable weight-loss drugs without ...
Pharm Exec10d
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 ...
FiercePharma10d
Supernus' 4th try proves the charm with long-awaited FDA approval for Parkinson's infusion pump Onapgo
Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump. | The device is ...