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 ...

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 ...

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

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

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

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

As 3D printing technologies gain ground in pharmaceutical manufacturing, experts in the field are being sought to help ...

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

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