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Amino Acid Count Determines Retatrutide's Biologic or Drug Classification

Artiva to Present AlloNK Data Showing CAR T-Like B-Cell Depletion in Rheumatologic Diseases at ACR 2026

Novartis Licenses Abogen's mRNA-Encoded CD19xCD3 T-Cell Engager ABO2203 for Autoimmune Diseases

CaseBioscience Joins $7.3 Million ARPA-H Team on Cell Preservation

AstraZeneca, Daiichi Sankyo, and Summit to Combine Datroway, Ivonescimab

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Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.

Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

Sanofi is paying Regeneron up to $8 billion to co-develop REGN20423 and 3 other long-acting antibodies beyond dupilumab (Dupixent).

Real-world data show weight loss after switching to the Wegovy pill, Lilly reports positive hand and foot atopic dermatitis data, and Teva wins FDA approval for a Xgeva biosimilar.

In the OCTANE real-world analysis presented at EASD 2026, adults who switched from injectable semaglutide or tirzepatide to once-daily oral semaglutide lost an average of 4.1% of body weight after 3 months.

Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.

More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.

Sponsored
Meeta Gulyani, Ecolab Life Sciences, shares where biomanufacturing is headed next and why the relationship between drug developers and their suppliers is changing along with it.

Novo Nordisk licenses a once-weekly oral GLP-1/GIP candidate, uniQure reports 48-month Huntington’s disease data, and AstraZeneca invests $2 billion in Summit Therapeutics.

Novo gains global rights, excluding Greater China, to HRS-1596, a phase 1-ready GLP-1/GIP dual receptor agonist that Hengrui says has potential for once-weekly oral dosing in obesity and type 2 diabetes.

NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.

Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.

Ivonescimab, in phase 3 trials across 8 tumor types, will be paired with sonesitatug vedotin in new gastrointestinal cancer trials.

Today’s biopharma news highlights how new data could reduce treatment burden, improve excipient information sharing, and shape future options for patients with difficult-to-treat cancers.

























