While Global Strategy sets the initial direction, true agility is sustained through a 360-degree loop that prioritises ...

The drug acts as a prostacyclin receptor agonist, which is a fairly crowded class with several approved oral, intravenous or ...

uniQure held a Type A meeting with the FDA at the end of January and, in a statement released today, said the agency "cannot agree that data from the Phase I/II studies, compared to an external ...

Novo Nordisk has said it will invest DKK 3.2 billion (€432 million) in a manufacturing plant in Ireland that will be used to ...

Roche's oral BTK inhibitor fenebrutinib has hit the spot in the final trial in its phase 3 programme, in relapsing multiple sclerosis (RMS), and is now being prepared for regulatory filings.

Recent transactions make clear that large pharmaceutical companies now view rare disease as a core area for sustained growth, rather than episodic deal-making. BioMarin’s acquisition of Amicus ...

Specifically, the CHMP has backed conditional marketing authorisation for Ojemda (tovorafenib) as a monotherapy for children ...

Atrium is led by Kathleen Gallagher, who was chief programme officer at Avidity before it was acquired by Novartis and will ...

Moderna has accused the FDA of moving the goal posts and being inconsistent with earlier advice. The FDA has refused to accept Moderna's marketing application of an mRNA-based seasonal influenza ...

The UK has lost its measles elimination status, according to the World Health Organization (WHO), after recording 2,911 laboratory-confirmed measles cases in England in 2024 – the highest number in a ...

Scientists and regulators have long acknowledged the weaknesses in traditional methods used to identify drugs that may harm the central nervous system. One in four safety-related failures arise from ...

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).