News

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 ...
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 ...
BioPharma Dive18m
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 ...
Fierce Pharma2h
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 ...
FoodNavigator-USA4h
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 ...
STAT2h
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 ...
PharmExec40m
FDA Approves Bayer’s Kerendia for Heart Failure with Preserved Ejection Fraction to Reduce Cardiovascular Death and Hospitalization Risk
Approval of Kerendia was based on results from the Phase III FINEARTS-HF trial, which demonstrated statistically significant ...
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 ...
Public Broadcasting Service (PBS)44m
WATCH LIVE: RFK Jr. makes ‘major announcement’ with FDA and International Dairy Foods Association
Agriculture Secretary Brooke Rollins and Health and Human Services Secretary Robert F. Kennedy Jr. will hold a news briefing ...
Undark Magazine9h
Safety of Foreign-Made Medications in Question After FDA Layoffs
Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.
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.