STAT1d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
Inquirer on MSN1d
FDA orders recall of antibiotics drug used vs pneumonia, bronchitis, UTI
The Food and Drug Administration (FDA) has ordered the recall of several batches of a brand of antibiotics used to treat ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
STAT7d
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
Cebu Daily News on MSN1d
FDA issues recall for ‘Triocef’ antibiotic due to quality defects
The Food and Drug Administration (FDA) has ordered the recall of several batches of Triocef oral drops (Cefixime), an antibiotic for bacterial infections like pneumonia, bronchitis, and UTI. In FDA ...
clickondetroit.com9d
FDA upgrades recall for broccoli sold at Walmart in Michigan, 19 other states to highest risk level
The U.S. Food and Drug Administration has upgraded the recall for broccoli sold at Walmart stores in 20 states to its most ...
The American Journal of Managed Care10d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
MedPage Today17h
Most Clozapine Prescribers Satisfied With REMS Program
Among 196 doctors who prescribed clozapine, 64% said the positive aspects of the REMS certification process outweighed the ...
FiercePharma2d
Regulatory tracker: Bayer, BridgeBio's ATTR drug wins approval in Europe
The Cardiovascular and Renal Drugs Advisory Committee will meet on February 24, according to an FDA document (PDF). The drug was approved by the agency in 2023 as a treatment for paroxysmal ...
What broccoli did FDA recall? Here's what to toss if it's in your freezer.
The lot code, UPC code and best-by date for Braga Fresh ready-to-eat 12-ounce Marketside Broccoli Florets, sold at Walmart in 20 states, including Texas.
Business Wire3d
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...