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 ...

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

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 ...

The genomic medicine space has seen incredible success, but investors are overlooking it. For once, it’s not efficacy that’s ...

23andMe is currently trading at around $3.15, down from more than $18 at the start of the year and more than $200 on its ...

Last night, news broke that President-Elect Donald Trump had nominated Robert F Kennedy Jr (aka RFK Jr) as US Health ...

AZ and Daiichi Sankyo have said that NICE's decision on Enhertu exposes how new methods and processes the agency uses to ...

Pelacarsen is in a cardiovascular outcomes trial in patients with elevated Lp (a) levels, with results expected in 2025, ...

In collaboration with AstraZeneca, Pfizer, Sanofi, and Ultragenyx, the 9th Commercializing Continuous Processing Summit ...

The company made its debut last year with a $51 million Series A and a licensing agreement with Astellas for a gene therapy ...

DXPs can now eliminate swivel chair processes. Commercial organisations can integrate existing systems with a DXP and have ...

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 ...