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.

As December 2022 closed out, Pfizer announced positive top-line results from its phase 3 BENEGENE-2 study evaluating fidanacogene elaparvovec (SPK-9001), its investigational gene therapy for ...

Apogee shares have spiked on data showing strong efficacy with its atopic dermatitis drug and the potential for dosing just two to four times a year.

AstraZeneca is backing up its big investments in antibody-drug conjugates (ADCs) with the construction of a $1.5bn new facility in Singapore.

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

MSD and Moderna start a third phase 3 trial of their V940 cancer vaccine, their second in early-stage lung cancer.