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 ...

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.

There is currently no approved treatment for intracerebral haemorrhagic stroke, but Belgian start-up Bioxodes hopes to change that.

AstraZeneca's lengthy and turbulent development of CTLA4 inhibitor tremelimumab has at least led to a regulatory approval as part of a combination therapy for advanced liver cancer. Tremelimumab ...

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area.