With Fayuvi now approved, Ultragenyx turns to building treatment-center capacity, securing payer access and identifying ...

The European Medicines Agency has endorsed Novo’s Frehemgo for hemophilia A, clearing the decks for its EU marketing approval.

Corcept Therapeutics’ Lifyorli and Impact Therapeutics’ Sepalna are on track for pan-EU marketing approval to treat patients ...

CEO Pascal Soriot’s share purchase suggests that AstraZeneca still doesn’t have the Phase III AVANZAR results for Datroway – which could be good news for the blockbuster bet.

Five companies revealed $100m-plus venture capital mega-rounds during the first half of September, already matching totals in ...

The NAD has asked Starkey Laboratories to modify or discontinue ad claims for its Omega AI hearing aid, including claims that were based on AI testing.

TG Therapeutics says Ocrevus biosimilars could boost Briumvi rather than erode its position, while arguing that deep discounts may be needed to sway payers and that its own 2042 patents could hinder ...

Medicines UK, the trade body for off-patent generic and biosimilar medicines, appointed Paul Burden, the UK's country head ...

An investor and a clinician take stock of where AI is creating durable value in pharma, and where the gap between promise and ...

The GDUFA IV commitment letter tackles two of the generic industry’s persistent concerns: facilities have had no direct line to the FDA on inspection findings that sink applications, and interim ...

Manufacturer funded, third-party patient assistance program may be modified or terminated after about two years based on the OIG’s assessment of the impact the Medicare Part D cap on out-of-pocket ...

Big pharma execs are opposed to US lawmakers restricting cross-border biotech deals, but now must argue against similar moves from China.