Oyster Recall Sparks Fourth Warning by FDA Over Norovirus Fears
The FDA has issued an urgent recall for shellstock oysters harvested last month in Washington state's Hammersley Inlet.
STAT1h
Trump’s FDA transition team takes shape with former Hahn adviser, courts top Capitol Hill aide
Trump's staff is laying the groundwork to prepare for a new FDA commissioner and make their mark at the agency.
The FDA’s Evolving Role in Public Health
A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...
Pharma giant seeks to join lawsuit against FDA over weight loss drugs
Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...
Targeted Oncology5h
FDA’s December 2024 Oncology Approvals and Designations
On December 20, 2024, the FDA granted accelerated approval to the combination of encorafenib (Braftovi), cetuximab (Erbitux), and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in metastatic ...
FiercePharma2h
Novo asks FDA to put kibosh on Victoza compounding amid GLP-1 outsourcing row
In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies to produce Victoza, also known as liraglutide, following a proposal by the ...
FDA testing aged raw cow’s milk cheese for bird flu
The Food and Drug Administration (FDA) will begin collecting samples of raw cow’s milk cheese from across the U.S. to test ...
The American Journal of Managed Care1d
FDA Approves First Subcutaneous Nivolumab Injection in Most Solid Tumors
FDA approves the first subcutaneous version of nivolumab, making PD-1 inhibitors available to new groups of patients.
FiercePharma1d
Lilly looks to 'protect its interests' by moving to join FDA lawsuit over compounded tirzepatide
After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking ...
McKnight's Senior Living2h
FDA approves Gemtesa for overactive bladder in men with BPH
Gemtesa is approved for men with overactive bladder symptoms who are receiving pharmacologic treatment for benign prostatic hyperplasia.
STAT3d
3 key issues to watch at the FDA as Trump takes office
With Donald Trump taking office and Robert F. Kennedy Jr. poised to assume the nation’s top health role, it seems the agency ...
medtechdive4h
FDA closes 2024 with string of early alerts on device safety risks
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.