Built specifically to mimic the native tricuspid anatomy, the implant is intended to address an unmet patient need.

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

Adults with mantle cell lymphoma who have already failed two or more treatments, including a BTK inhibitor, now have a new ...

The US Food and Drug Administration (FDA) should establish a public database of medical device labels that is accessible to patients, healthcare providers, and consumers. This database would help ...

NeuroPace NPCE recently announced that the FDA has approved its ECoG Assistant, its first AI-driven feature to assist ...

Foundation Medicine previously received companion diagnostic approval for its FoundationOne Liquid CDx assay alongside EMD Serono's Tepmetko.

Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients eligible for treatment who could benefit from TEPMETKO®This is Foundation Medicine’s first real-world ...

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

April 14 (Reuters) - The U.S. Food and Drug Administration has asked Eli Lilly (LLY.N), opens new tab for more data on liver injury linked to its newly approved obesity pill, according to a letter ...

The US Food and Drug Administration (FDA) on Wednesday released a draft guidance for public consultation providing recommendations for drugmakers on using the agency’s inactive ingredient database ...

Nearly two decades ago, Congress passed the US Food and Drug Administration (FDA) Amendments Act of 2007 , partially in response to several high-profile safety-related concerns ab ...