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 ...
Vepdegestrant, first PROTAC in breast cancer, improved PFS vs fulvestrant in ESR1-mutant ER+/HER2− disease after endocrine therapy plus CDK4/6i (5.0 vs 2.1 months; HR 0.57). Decitabine/cedazuridine ...
Morning Overview on MSN
The FDA just cleared Beqalzi for mantle cell lymphoma — sonrotoclax becoming the latest targeted therapy for a relapsed blood cancer with few options
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 ...
Morning Overview on MSN
Gladstone and UCSF scientists screened pre-existing drug databases to find Alzheimer’s reversers, skipping the years it takes to invent new ones
Scientists at Gladstone Institutes and UCSF have turned to computational shortcuts to find Alzheimer’s treatments among drugs ...
Foundation Medicine previously received companion diagnostic approval for its FoundationOne Liquid CDx assay alongside EMD Serono's Tepmetko.
2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products
How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025? While it would be presumptuous to base conclusions solely ...
The US Food and Drug Administration (FDA) on Wednesday released a draft guidance for public consultation providing recommendations for drugmakers on using the agency’s inactive ingredient database ...
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 ...
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