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.

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 ...

The FDA has a new director for the Center for Drug Evaluation and Research (CDER), with biopharma industry executive George Tidmarsh named to the role. The appointment comes more than six months ...

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.

Gilead Sciences has made another foray into the natural killer (NK) cell category, paying $300 million upfront to access Dragonfly Therapeutics' TriNKET platform to find therapies for cancer and ...