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 ...

NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it ...

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 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 ...

Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in ...

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

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

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

A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic ...