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

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) ...

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

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, ...

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

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 ...

One of the big questions going into the phase I readout for Metsera Inc.’s amylin analogue, MET-233i, was whether findings would support once-monthly dosing for the potential obesity candidate. They ...

Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June ...

Turning the human body into a biofactory of precision protein therapeutics is the focus of newly launched Signify Bio, which ...