The FDA’s verdict on Poherdy comes amid Perjeta creator Genentech’s patent infringement lawsuit against Organon and Shanghai ...

A CHMP panel has recommended the high-dose version’s approval, countering an FDA rejection for the drug in recent months.

Medicxi will use the €500m kitty to continue supporting drug hunters and entrepreneurs in creating asset-focused ...

The fund will participate in follow-on and initial rounds, focusing on biotech and medtech ventures across core markets.

Sarepta has received US FDA approval for updated prescribing information for Elevidys, an AAV-based gene transfer therapy.

MSD has now agreed two deals around the $10bn mark in 2025 as it looks to shore up its pipeline with Keytruda’s looming ...

Eisai and Biogen have announced UK MHRA approval for Leqembi for intravenous (IV) maintenance dosing to treat early Alzheimer ...

Komzifti now becomes the first once-daily targeted therapy for r/r AML, though it will have to fight Syndax’s Revuforj for ...

The two drugmakers swiftly denied any affiliation with Mangoceuticals, who claimed it had partnered with them.

The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the ...

The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...

If successful in the Phase III trial, VK2735 would enter direct competition with established dual agonists such as Eli ...