Rare disease is a major – and growing – area of clinical research and drug development. Of the FDA’s 46 novel drug approvals ...

With the CHMP affirmation, Moderna is on course to get EU approval for its fourth vaccine product and break new ground in ...

The IPO, which saw 25 million shares sold at $16, in the middle of the $15 to $17 range predicted by the company, continues a ...

Two TROP2-targeting antibody-drug conjugates, Datroway and Trodelvy, have new data suggesting they could become options for previously untreated patients with triple-negative breast cancer (TNBC).

Boehringer Ingelheim has become the second company to get a product approved under the FDA's national priority voucher ...

Eli Lilly's oral GLP-1 agonist orforglipron was more effective than Novo Nordisk's recently launched Wegovy pill in a head-to ...

Oxford-based Sitryx, which also has operations in Boston in the US, was founded in 2018 with seed funding from SV Health ...

Clinical trials are full of moving parts and, despite recent technological advances, they still come with manual processes ...

When outcome selection and prioritisation are defined early in development, the evidence base supports continuity from trial ...

Released ahead of tomorrow's Rare Diseases Day, the report (PDF) says that people affected by rare conditions face "profound ...

Asahi Kasei has agreed a €780 million (around $920 million) price tag for Wuppertal-based Aicuris, which is hoping for FDA ...

According to committee chairman Rick Scott (R-FL), "inconsistent review practices, shifting standards, and redundant, often-late-appearing data requests" are delaying patient access to safe and ...