News

Fierce Pharma17h
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 ...
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 ...
GSK seeks FDA nod for expanded use of RSV vaccine in adults
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...
FoodNavigator-USA20h
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 ...
BioPharma Dive15h
FDA rejects Ultragenyx gene therapy over manufacturing concerns
While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...
STAT17h
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 ...
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.