Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the ...
Efficacy among previously treated HR+/HER2- breast cancer patients looked in line with Merck/Kelun’s sac-TMT, but an analyst ...
A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start ...
Staff who left the FDA in recent months are being enticed to come back by efforts to return to historical operations, but ...
The FDA's drugs and biologics center directors said lessons from the rare disease “mindset shift” could be leveraged for ...
The biotech plans to seek full approval in the fourth quarter based on positive data from the Phase III ORIGIN 3 trial.
Tango’s PRMT5 inhibitor combined with Revolution Medicines’ Rasonque shows durability of effect in updated data from a Phase ...
The row between big pharma and Germany’s government has intensified, with many firms threatening to limit investment in the ...
As 3D printing technologies gain ground in pharmaceutical manufacturing, experts in the field are being sought to help ...
CMR Surgical CEO Massimiliano Colella said Stryker’s $400m investment is structured so CMR keeps training, marketing and ...
One patient died 44 days after receiving zolacabtagene autoleucel in the Phase I Breakfree-2 study in highly active relapsing ...
Genmab’s rinatabart sesutecan (Rina-S) reduced risk of disease progression by 71% and risk of death by 57% in platinum-resistant ovarian cancer (PROC) regardless of FRα expression, a competitive ...
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