The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a ...

Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange ...

The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech ...

The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable ...

Sarepta Therapeutics Inc. made known a third gene therapy death, this time with SRP-9004 for limb-girdle muscular dystrophy. The patient was a late-stage, non-ambulatory 51-year-old man participating ...

The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it ...

The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the ...

Fragile X syndrome (FXS), the most common inherited cause of intellectual disability and autism, is caused by silencing of the Fmr1 gene, leading to a lack of the FMRP protein, which regulates protein ...

After expanding development of DM-199 (rinvecalinase alfa) into preeclampsia last year, Diamedica Inc. rolled out early phase ...

Splicing is a process necessary for the correct synthesis of proteins and an essential step in gene expression. An impaired ...

SK Bioscience Ltd. announced that the company has submitted an investigational new drug (IND) application to the South Korean ...

Xeltis BV is seeing encouraging preliminary data for Xabg, its coronary artery bypas conduit, from two clinical trials underway in Europe and South America. The data shows positive safety and patency ...