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

CMR Surgical CEO Massimiliano Colella said Stryker’s $400m investment is structured so CMR keeps training, marketing and ...

P&G plans to help Thorne scale its business with supply chain, ingredient qualification and marketing capabilities while ...

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 ...

One patient died 44 days after receiving zolacabtagene autoleucel in the Phase I Breakfree-2 study in highly active relapsing ...

The row between big pharma and Germany’s government has intensified, with many firms threatening to limit investment in the ...

The FDA soon will launch a pilot giving nonprescription drug sponsors early, structured talks with the agency, which should ...

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

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

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

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