Pharminent · Daily Brief
FDA approves Lilly’s once-weekly basal insulin Onswik for type 2 diabetes
The FDA approved Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults living with type 2 diabetes. Lilly said Onswik is designed to reduce injections by more than 300 per year versus once-daily basal insulin.
Eli Lilly →$LLYFDA advisers vote in favor of Grail’s Galleri multi-cancer blood test
FDA expert advisers voted in favor of Grail’s Galleri blood test for detecting multiple cancers, with some panelists expressing misgivings about the test’s efficacy.
Pharmaphorum →FDA commissioner nominee Heidi Overton to face Senate confirmation hearing
Heidi Overton, President Trump’s pick to lead the FDA, will take questions at a Senate confirmation hearing.
STAT →Federal court enters consent decree against Gold Star Distribution
An FDA investigation resulted in a federal court order dated September 21, 2026, stopping warehouse operator Gold Star Distribution from distributing FDA-regulated products, including food, drugs, medical devices and cosmetics, until it brings its operations into compliance with federal legal requirements.
FDA →Roche’s sefaxersen meets endpoint in phase 3 IgA nephropathy trial
Roche reported that sefaxersen, an antisense oligonucleotide licensed from Ionis Pharmaceuticals, achieved statistically significant and clinically meaningful results in a phase 3 trial in immunoglobulin A nephropathy (IgAN).
MedCity News →$RHHBY$IONSKyverna reports one-year data for autoimmune CAR-T miv-cel
Kyverna Therapeutics reported long-term clinical data for miv-cel showing sustained efficacy at one year alongside an unblemished safety profile for the potential first-in-class candidate.
Fierce Biotech →Lilly commits $100M upfront in five-target InnoCare discovery pact
Eli Lilly has committed $100 million in upfront and near-term payments to China’s InnoCare Pharma to form a five-target drug discovery partnership. The agreement includes up to $3.25 billion in milestone payments.
Fierce Biotech →$LLYEnveda raises $311M in venture funding for AI drug discovery
Enveda, which uses AI tools to mine plants and microbes for drug prospects, raised $311 million in venture funding. The company has three candidates in human testing for immune diseases and obesity.
BioPharma Dive →Basecamp Research secures $140M Series C for AI-designed therapies
Basecamp Research raised $140 million in a Series C round to train a new generation of its EDEN biological foundation models and advance AI-designed therapies toward clinical development.
Pharmaceutical Technology →Nine pharma leaders call for action on European biotech decline
Nine pharmaceutical industry leaders signed a letter warning about a slump that has seen Europe lose ground to the U.S. and China, calling for speedier clinical trials, intellectual property protections and “fiscal flexibility.”
BioPharma Dive →Teal Health raises $22M for at-home HPV cervical cancer screening device
Teal Health secured $22 million in a Series A round for its at-home HPV cervical cancer screening device. The round was led by .406 Ventures, with participation from Emerson Collective (managed by Yosemite), Forerunner, Serena Ventures and Japan-based MPower Partners.
MedCity News →Lilly stops publicly listing its phase 1 pipeline programs
Lilly no longer publicly lists its earliest clinical programs, removing phase 1 candidates from its disclosed pipeline.
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