The word from the FDA is that Prasad has come back at the request of the regulator's Commissioner, Marty Makary, who ...

More details have emerged of a UK plan for new medicines to get simultaneous decisions from the MHRA and NICE on their use by the NHS.

Jazz has reached an agreement to buy Chimerix for around $935 million, adding a brain cancer drug heading for an FDA approval decision in August.

GSK has become the latest drugmaker to run into difficulties in developing a drug targeting the immune checkpoint receptor TIM-3.

Takeda has said it intends to move quickly ahead with regulatory filings for oveporexton, its orexin agonist for sleep disorder narcolepsy, after a clean sweep of positive efficacy data in two ...

OpenEvidence has raised $210m to expand the capabilities of its physician decision-making tool and launch a new service offering 'PhD-level' research.

Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy (GA), a complication of age-related macular degeneration (AMD), as it prepares to test it in a ...

Three key lessons the past five years of challenges and experience have taught us that we can use to move the biosimilars market forward.

Moderna has announced a new cost-cutting round as it tries to pare down its annual costs, with a new commitment to cut 10% off its headcount by the end of the year. The target is to reduce its ...

Bayer has added another phase 3 trial into its registration programme for oral Factor XIa inhibitor asundexian, signalling growing confidence in a drug that generated mixed results in phase 2. The ...

Brain-computer interface firm Neuralink has completed a $650m financing that it says will help to "bring our technology to more people" ...

The revamp of French drugmaker Ipsen has continued with a takeover agreement for US counterpart Epizyme and its cancer therapy Tazverik, in a deal valued at a little under $250 million.