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 ...

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.

Bayer has joined forces with electronics group Samsung to carry out an observational study on sleep disturbances during menopause ...

Shionogi has added to its antibiotics pipeline by taking an option on a preclinical-stage candidate from BioVersys for non-tuberculous mycobacteria.

Google has invested £20 million in Vaccitech, an Oxford biotech working on novel treatments including a universal flu vaccine.

NHS England has agreed a confidential deal with Orchard Therapeutics that will allow access to Libmeldy – a gene therapy for a rare childhood disease that is thought to be the most expensive ...