News

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 ...
TCTMD6m
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 ...
STAT4hOpinion
The FDA commissioner is a gifted talker — but the job is about more than that
FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...
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 ...
Targeted Oncology36m
FDA's Oncologic Drugs Advisory Committee Casts Interesting Votes
The FDA evaluates glofitamab and daratumumab for lymphoma and myeloma treatments, highlighting trial demographics and ...
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 ...
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 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 ...
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 ...
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 ...
Capricor Therapeutics: Buying Opportunity Following FDA's Complete Response Letter
Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.