Gepotidacin was approved by the FDA earlier this year, under the Blujepa brand, as the first oral antibiotic to offer a new ...

One near-term rival is Johnson & Johnson's FcRn inhibitor nipocalimab, which started a phase 3 programme last December.

Haematological cancers are a recognised potential side effect with Skysona and were already mentioned in a boxed warning on the gene therapy's approved labelling. The new label restricts use of the ...

One major and often overlooked factor contributing to this imbalance is the way health outcomes are measured in clinical ...

Boehringer Ingelheim's bid to return to the oncology arena has been achieved with an FDA approval for Hernexeos, a new, ...

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

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.

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

Uniting 100+ precision medicine leaders from biopharma, diagnostic development, regulation, and healthcare institutes, the ...

In its second-quarter financial filing, Iovance said it was planning to shed 19% of its workforce of more than 630 in order ...

We assume that what worked in the 1950s still works now. We assume that more budget is the only answer. Yet, AI can help in transformative ways if adopted at scale. If AI were scaled across the NHS to ...

The complicated legal wrangling has been brought to a close after CureVac and BioNTech settled their mRNA patent litigation ...