News

MedPage Today3m
Finerenone Gets Expanded FDA Approval in Heart Failure
The FDA expanded the indication for finerenone (Kerendia) in heart failure (HF), drug manufacturer Bayer announced.
TCTMD11m
FDA Approves Finerenone for HF Patients With Mildly Reduced or Preserved EF
The US Food and Drug Administration has approved the use of finerenone (Kerendia) in heart failure (HF) patients with mildly ...
Mushrooms are being recalled over Listeria fears in two separate FDA notices: Avoid these products
Needle mushrooms and other mushroom products are impacted by two separate recall notices from the Food and Drug ...
FDA approves new blue food dye derived from gardenia fruit
The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering evergreen, for use in a variety of drinks and candies.
GSK seeks FDA nod for expanded use of RSV vaccine in adults
(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to ...
FDA Issues Risk Warning as Apples Recalled in Four States
A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...
FDA issues highest risk warning after mushrooms recalled nationwide
The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...
Fierce Pharma3h
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
BioPharma Dive1h
FDA rejects Ultragenyx gene therapy over manufacturing concerns
While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...
FoodNavigator-USA6h
FDA urges infant and children’s food brands to improve recall communications under Operation Stork Speed
FDA is urging manufacturers of infant formula, baby food and children’s nutrition products to sharpen their recall ...
STAT3h
FDA declines to approve Ultragenyx gene therapy
In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy ...
FDA rejects Ultragenyx rare disease gene therapy around manufacturing issues
A rare metabolic condition affecting children may have to wait longer for a potential one-time treatment as Ultragenyx ...