The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died, but that won't cause the study to be halted. The FDA has allowed the company ...

Elon Musk's brain-computer interface (BCI) company Neuralink has been given the green light to test its device in tetraplegic patients in Canada – the first international trial of the technology. The ...

US President-Elect Donald Trump is reported to be considering the nomination of Johns Hopkins surgeon and writer Martin Makary to lead the FDA after he takes office in January. The rumour was ...

AstraZeneca's anticoagulant reversal agent Andexxa was given an accelerated approval by the FDA in 2018, but the company's plan to get that upgraded to a full approval is facing some pushback. At an ...

Jazz Pharmaceuticals has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary ...

The creation of these ‘pharmacy deserts’ exacerbates health inequalities and hinders the ongoing effort to shift the focus of healthcare towards prevention. Supporting community pharmacies, then, is ...

Generic drugmaker Accord Healthcare has announced a £50 million ($65 million) investment in the UK that will include the construction of a new medicines manufacturing facility. The new plant ...

Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on ...

The protracted legal wrangling between Apple and health wearable company Masimo has resulted in a nominal win for the tech giant – but failed to achieve its objectives. Apple and Masimo have ...

Bayer has entered into an alliance with Impli, tapping into the start-up's implantable hormone-monitoring platform, which has potential in fertility treatment and other indications. Impli's ...

A US district court has granted an injunction sought by Incyte on the launch of Sun Pharma's recently approved Leqselvi for alopecia areata. In a brief filing with the National Stock Exchange (NSE ...

Data – it’s everywhere! Especially in clinical trials, where an average trial of about 2,000 patients can expect to produce 3,000,000 points of data across labs, vitals, medications, and ...