With the U.S. FDA’s approval of Enflonsia (cesrovimab) to prevent respiratory syncytial virus (RSV) infection lower ...

Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its ...

Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting ...

Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated ...

Researchers at the Massachusetts Institute of Technology and Recursion Pharmaceuticals Inc. have released an open-source AI ...

Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, ...

The European Commission is seeking feedback from stakeholders on the oversight of high-risk AI products, one objective of ...

Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital ...

Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over ...

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop ...

In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low ...

Absent extraordinary circumstances, the Patent Trial and Appeal Board “should never cancel claims it has not determined to be unpatentable as a sanction” for misconduct during a board proceeding, ...