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 ...

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 ...

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 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 ...

Just hours after reports began surfacing June 9 that four of the 17 members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) had been terminated, Health and Human Services (HHS) ...