The Swiss company's candidate has comfortably surpassed Lumakras and Krazati; significant survival data and an impressive ...

Australia’s regulator weighs in on debate about whether intention or function should decide regulatory status for AI products ...

Another positive study for AstraZeneca’s PD-L1 blocker Imfinzi could send it into a third bladder cancer population, while ...

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 ...

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 ...

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

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

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

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 ...