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 ...

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 ...

Recent transactions make clear that large pharmaceutical companies now view rare disease as a core area for sustained growth, ...

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 ...

Glimmers of a resurgence in biotech IPO activity in 2026 have continued with the news that two more companies – Belgium's AgomAb Therapeutics and SpyGlass Pharma of the US – are sizing up investor ...

Novo Holdings' $16.5 billion acquisition of US contract development and manufacturing organisation (CDMO) Catalent has been completed, after months of debate over potential antitrust issues. The ...

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 ...

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ...