The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug ...

The Twin Tube made by Vyaire Medical is being recalled due to the potential for the nozzle to separate during patient use.

Guardant intends to market the blood test as a non-invasive alternative for patients who can’t access screening colonoscopy.

In a phase 3 trial, those taking Awiqli were 80 percent more likely to experience hypoglycemia than those taking insulin degludec.

Several senators on both sides of the aisle brought up the many bipartisan bills that have passed the House and Senate committees in recent years.

Sandoz is withdrawing from the UK’s Prescription Medicines Code of Practice Authority (PMCPA) after being dinged for promotional wording of its biosimilar natalizumab in official documents presented ...

For the third time this year, the FDA has deemed an Abbott recall of its HeartMate 3 Left Ventricular Assist System (LVAS) as Class I, the most serious type of recall, following 81 reported incidents, ...

FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...

An updated version of the Biosecure Act gives US businesses until 2032 to decouple from four Chinese biotech companies identified as being of “particular concern” over data mining on behalf of the ...

Sen. Bernie Sanders (I-Vt.) has raised his battle flag against high drug prices on a crumbling hill, according to a conservative think tank that’s picking apart a study supporting Sanders’ views on ...

If CDRH doesn’t get $11.5 million from Congress this year to keep up its program to prevent medical device supply chain disruptions, the program will go dark next year, said center director Jeff ...

FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...