Biotech/Merck’s sacituzumab tirumotecan is set to supersede chemotherapy in combination with Keytruda in first-line, ...

Efficacy among previously treated HR+/HER2- breast cancer patients looked in line with Merck/Kelun’s sac-TMT, but an analyst ...

Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the ...

A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start ...

The biotech plans to seek full approval in the fourth quarter based on positive data from the Phase III ORIGIN 3 trial.

Staff who left the FDA in recent months are being enticed to come back by efforts to return to historical operations, but ...

Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence ...

Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in ...

The FDA's drugs and biologics center directors said lessons from the rare disease “mindset shift” could be leveraged for ...

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 ...